protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03201965 | 11.1 | Subject Information | 11.1. Subject Information The primary analysis population will be the intent-to-treat (ITT) population, which will include all randomized subjects. Safety will be evaluated for the population of all treated subjects. The per protocol population is a subset of the ITT population defined as those subjects who have no maj... | [] |
NCT03201965 | 11.2 | Sample Size Determination | 11.2. Sample Size Determination The sample size for this study is based on the alternative hypothesis of a 15% improvement in overall CHR. Taking an overall CHR rate estimated to be 25% for the CyBorD arm (Palladini 2015),[38](#page-110-3) adding a 15% improvement translates to an overall CHR rate of 40% for the CyBorD... | [] |
NCT03201965 | 11.3 | Efficacy Analyses | 11.3. Efficacy Analyses The primary comparison of the 2 randomized treatments will be made with respect to overall CHR based on IRC assessment using the Cochran-Mantel-Haenszel (CMH) chi square test in the ITT population stratified by cardiac risk (Dispenzieri 2014; Palladini 2016)[11](#page-109-1)[,36](#page-110-0) (S... | [] |
NCT03201965 | 11.4 | Pharmacokinetic Analyses | 11.4. Pharmacokinetic Analyses Pharmacokinetic data will be listed by visit for the pharmacokinetic-evaluable population, defined as subjects assigned to Treatment Arm B (CyBorD plus daratumumab) who have received at least 1 dose of daratumumab and have at least 1 pharmacokinetic sample concentration value after the fi... | [] |
NCT03201965 | 11.5 | Immunogenicity Analyses | 11.5. Immunogenicity Analyses The incidence of antibodies to daratumumab and antibodies to rHuPH20 will be summarized for all subjects assigned to Treatment Arm B (CyBorD plus daratumumab) who receive at least 1 dose of daratumumab and have appropriate samples for detection of antibodies to daratumumab or rHuPH20 after... | [] |
NCT03201965 | 11.6 | Pharmacokinetic/Pharmacodynamic Analyses | 11.6. Pharmacokinetic/Pharmacodynamic Analyses To understand the relationship between serum concentrations of daratumumab and biomarkers or endpoints of clinical efficacy or safety, additional pharmacokinetic/pharmacodynamic modeling may be performed, which will be summarized in a separate report. | [] |
NCT03201965 | 11.7 | Biomarker Analyses | 11.7. Biomarker Analyses Any biomarker measurements will be listed, tabulated, and where appropriate, plotted. As this is an open-label study with an active control treatment, statistical analyses will be done to aid in the understanding of results. Results of biomarker and pharmacodynamic analyses may be presented in ... | [] |
NCT03201965 | 11.8 | Patient-Reported Outcomes | 11.8. Patient-Reported Outcomes EORTC QLQ-C30 scale and single-item scores, EQ-5D-5L visual analog scale and utility values, and SF-36v2 component summary and domain scores will be summarized at each time point. Treatment effect will be assessed by change from baseline at each time point summarized descriptively by tre... | [] |
NCT03201965 | 11.9 | Safety Analyses | 11.9. Safety Analyses
Adverse Events The verbatim terms used in the eCRF by investigators to identify AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse events are AEs with onset during the Treatment Phase or that are a consequence of a pre-existing condition ... | [
"Adverse Events",
"Clinical Laboratory Tests",
"Electrocardiogram (ECG)",
"Transthoracic Echocardiogram (TTE) or Other Assessment of Cardiac Function",
"Vital Signs",
"Physical Examination and ECOG"
] |
NCT03201965 | 11.10 | Interim Analysis | 11.10. Interim Analysis Two interim analyses are planned for the randomized study. The first interim will occur after the first 30 subjects are treated for at least 1 cycle (CyBorD and CyBorD plus daratumumab). The purpose of the first interim analysis is to have a comprehensive evaluation of safety. The second interim... | [] |
NCT03201965 | 12 | ADVERSE EVENT REPORTING | 12. ADVERSE EVENT REPORTING Timely, accurate, and complete reporting and analysis of safety information from clinical studies are crucial for the protection of subjects, investigators, and the sponsor, and are mandated by regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in confor... | [] |
NCT03201965 | 12.1 | Definitions | 12.1. Definitions | [] |
NCT03201965 | 12.1.1 | Adverse Event Definitions and Classifications | 12.1.1. Adverse Event Definitions and Classifications
Adverse Event An AE is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavo... | [
"Adverse Event",
"Serious Adverse Event",
"Unlisted (Unexpected) Adverse Event/Reference Safety Information",
"Adverse Event Associated With the Use of the Drug"
] |
NCT03201965 | 12.1.2 | Attribution Definitions | 12.1.2. Attribution Definitions
Not Related An AE that is not related to the use of the drug.
Doubtful An AE for which an alternative explanation is more likely, eg, concomitant drug(s), concomitant disease(s), or the relationship in time suggests that a causal relationship is unlikely.
Possible An AE that might be ... | [
"Not Related",
"Doubtful",
"Possible",
"Probable",
"Very Likely"
] |
NCT03201965 | 12.1.3 | Severity Criteria | 12.1.3. Severity Criteria The severity assessment for an AE or SAE should be completed using the NCI-CTCAE version 4.03. Any AE or SAE not listed in the NCI-CTCAE version 4.03 will be graded according to investigator clinical judgment by using the standard grades as follows: Grade 1 (Mild): asymptomatic or mild symptom... | [
"Activities of Daily Living (ADL)"
] |
NCT03201965 | 12.2 | Special Reporting Situations | 12.2. Special Reporting Situations Safety events of interest on a sponsor study drug that may require expedited reporting or safety evaluation include, but are not limited to: - Overdose of a sponsor study drug. - Suspected abuse/misuse of a sponsor study drug - Inadvertent or accidental or occupational exposure to a s... | [] |
NCT03201965 | 12.3 | Procedures | 12.3. Procedures | [] |
NCT03201965 | 12.3.1 | All Adverse Events | 12.3.1. All Adverse Events All AE and special reporting situations, whether serious or non-serious, will be reported from the time a signed and dated ICF is obtained until 30 days after the last dose of study treatment (cyclophosphamide, bortezomib, dexamethasone or daratumumab), until the subject withdraws consent for... | [] |
NCT03201965 | 12.3.2 | Serious Adverse Events | 12.3.2. Serious Adverse Events All SAEs occurring during the study must be reported to the appropriate sponsor contact person by study-site personnel within 24 hours of their knowledge of the event. Information regarding SAEs will be transmitted to the sponsor using the Serious Adverse Event Form, which must be complet... | [] |
NCT03201965 | 12.3.3 | Pregnancy | 12.3.3. Pregnancy All initial reports of pregnancy must be reported to the sponsor by the study-site personnel within 24 hours of their knowledge of the event using the appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous abortion, stillbirth, and congenital anomaly) are considered SAEs... | [] |
NCT03201965 | 12.4 | Contacting Sponsor Regarding Safety | 12.4. Contacting Sponsor Regarding Safety The names (and corresponding telephone numbers) of the individuals who should be contacted regarding safety issues or questions regarding the study are listed in the Contact Information page(s), which will be provided as a separate document. | [] |
NCT03201965 | 13 | PRODUCT QUALITY COMPLAINT HANDLING | 13. PRODUCT QUALITY COMPLAINT HANDLING A product quality complaint (PQC) is defined as any suspicion of a product defect related to manufacturing, labeling, or packaging, ie, any dissatisfaction relative to the identity, quality, durability, or reliability of a product, including its labeling or package integrity. A PQ... | [] |
NCT03201965 | 13.1 | Procedures | 13.1. Procedures All initial PQCs must be reported to the sponsor by the study-site personnel within 24 hours after being made aware of the event. If the defect is combined with an SAE, the study-site personnel must report the PQC to the sponsor according to the SAE reporting timelines (refer to Section [12.3.2,](#page... | [] |
NCT03201965 | 13.2 | Contacting Sponsor Regarding Product Quality | 13.2. Contacting Sponsor Regarding Product Quality The names (and corresponding telephone numbers) of the individuals who should be contacted regarding product quality issues are listed in the Contact Information page(s), which will be provided as a separate document. | [] |
NCT03201965 | 14 | STUDY DRUG INFORMATION | 14. STUDY DRUG INFORMATION | [] |
NCT03201965 | 14.1 | Physical Description of Study Drug(s) | 14.1. Physical Description of Study Drug(s) The daratumumab SC supplied for this study is a colorless to yellow liquid and sterile concentrate of 120 mg/mL as a liquid vial. The study agent should be essentially free of visible particulate matter at the time of syringe preparation and drug product administration. Each ... | [] |
NCT03201965 | 14.2 | Packaging | 14.2. Packaging Daratumumab SC is supplied in glass vials containing daratumumab at a concentration of 120 mg/mL and rHuPH20 at a concentration of 2000 U/mL (~20 µg/mL). It will be supplied to the site/pharmacy as open-label supply. | [] |
NCT03201965 | 14.3 | Labeling | 14.3. Labeling Study drug labels will contain information to meet the applicable regulatory requirements. Each vial will contain a study-specific label with a unique identification number. | [] |
NCT03201965 | 14.4 | Preparation, Handling, and Storage | 14.4. Preparation, Handling, and Storage Daratumumab SC product must be stored in the original carton in a refrigerator at controlled temperatures ranging from 2°C to 8°C until it is removed for dose preparation. Study drug must not be utilized after the expiry date printed on the label. Daratumumab SC product must be ... | [] |
NCT03201965 | 14.5 | Bortezomib, Cyclophosphamide, and Dexamethasone | 14.5. Bortezomib, Cyclophosphamide, and Dexamethasone Bortezomib may be provided in 3.5 mg single-use vials as a lyophilized powder or as prescribed by the investigator. Cyclophosphamide may be provided in 50 mg oral tablets or as prescribed by the treating physician. Dexamethasone may be provided in 4 mg oral tablets ... | [] |
NCT03201965 | 14.6 | Drug Accountability | 14.6. Drug Accountability The investigator is responsible for ensuring that all study drug received at the site is inventoried and accounted for throughout the study. The study drug administered to the subject must be documented on the drug accountability form. All study drug will be stored and disposed of according to... | [] |
NCT03201965 | 15 | STUDY-SPECIFIC MATERIALS | 15. STUDY-SPECIFIC MATERIALS The investigator will be provided with the following supplies: - Study Protocol and Amendments - IB for daratumumab and rHuPH20 - Site Investigation Product Procedures Manual (SIPPM) - Investigational Product Preparation Instructions (IPPI) - Laboratory Manual - IWRS Manual - eCRF Completio... | [] |
NCT03201965 | 16 | ETHICAL ASPECTS | 16. ETHICAL ASPECTS | [] |
NCT03201965 | 16.1 | Study-Specific Design Considerations | 16.1. Study-Specific Design Considerations The primary safety profile of daratumumab is consistent with IRRs. Based on the mechanism of action of daratumumab, a potential risk could be infection; therefore, the protocol requires the review of hematological laboratory results prior to daratumumab SC-administration. CD38... | [] |
NCT03201965 | 16.2 | Regulatory Ethics Compliance | 16.2. Regulatory Ethics Compliance | [] |
NCT03201965 | 16.2.1 | Investigator Responsibilities | 16.2.1. Investigator Responsibilities The investigator is responsible for ensuring that the study is performed in accordance with the protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable regulatory and country-specific requirements. Good Clinical Practice is an international ethical and scie... | [] |
NCT03201965 | 16.2.2 | Independent Ethics Committee or Institutional Review Board | 16.2.2. Independent Ethics Committee or Institutional Review Board Before the start of the study, the investigator (or sponsor where required) will provide the IEC/IRB with current and complete copies of the following documents (as required by local regulations): - Final protocol and, if applicable, amendments - Sponso... | [] |
NCT03201965 | 16.2.3 | Informed Consent | 16.2.3. Informed Consent Each subject (or legally acceptable representative) must give written consent according to local requirements after the nature of the study has been fully explained. The ICF(s) must be signed before performance of any study-related activity. The ICF(s) that is/are used must be approved by both ... | [] |
NCT03201965 | 16.2.4 | Privacy of Personal Data | 16.2.4. Privacy of Personal Data The collection and processing of personal data from subjects enrolled in this study will be limited to those data that are necessary to fulfill the objectives of the study. These data must be collected and processed with adequate precautions to ensure confidentiality and compliance with... | [] |
NCT03201965 | 16.2.5 | Long-Term Retention of Samples for Additional Future Research | 16.2.5. Long-Term Retention of Samples for Additional Future Research Samples collected in this study may be stored for up to 15 years from last patient out (or according to local regulations) for additional research. Samples will only be used to understand daratumumab, to understand amyloidosis, to understand differen... | [] |
NCT03201965 | 16.2.6 | Country Selection | 16.2.6. Country Selection This study will only be conducted in those countries where the intent is to launch or otherwise help ensure access to the developed product if the need for the product persists, unless explicitly addressed as a specific ethical consideration in Section [16.1,](#page-97-2) Study-Specific Design... | [] |
NCT03201965 | 17 | ADMINISTRATIVE REQUIREMENTS | 17. ADMINISTRATIVE REQUIREMENTS | [] |
NCT03201965 | 17.1 | Protocol Amendments | 17.1. Protocol Amendments Neither the investigator nor the sponsor will modify this protocol without a formal amendment by the sponsor. All protocol amendments must be issued by the sponsor, and signed and dated by the investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or when the... | [] |
NCT03201965 | 17.2 | Regulatory Documentation | 17.2. Regulatory Documentation | [] |
NCT03201965 | 17.2.1 | Regulatory Approval/Notification | 17.2.1. Regulatory Approval/Notification This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities in each respective country, if applicable. A study may not be initiated until all local regulatory requirements are met. | [] |
NCT03201965 | 17.2.2 | Required Prestudy Documentation | 17.2.2. Required Prestudy Documentation The following documents must be provided to the sponsor before shipment of study drug to the study site: - Protocol and amendment(s), if any, signed and dated by the principal investigator - A copy of the dated and signed (or sealed, where appropriate per local regulations), writ... | [] |
NCT03201965 | 17.3 | Subject Identification, Enrollment, and Screening Logs | 17.3. Subject Identification, Enrollment, and Screening Logs The investigator agrees to complete a subject identification and enrollment log to permit easy identification of each subject during and after the study. This document will be reviewed by the sponsor study-site contact for completeness. The subject identifica... | [] |
NCT03201965 | 17.4 | Source Documentation | 17.4. Source Documentation At a minimum, source documents consistent in the type and level of detail with that commonly recorded at the study site as a basis for standard medical care must be available for the following: subject identification, eligibility, and study identification; study discussion and date of signed ... | [
"Discharge summaries"
] |
NCT03201965 | 17.5 | Case Report Form Completion | 17.5. Case Report Form Completion Electronic data capture (eDC) will be used for this study. Electronic case report forms are provided for each subject in electronic format. Study-site personnel must log in eDC via a secure manner - personal password. The individual password must keep confidential for personal use. The... | [] |
NCT03201965 | 17.6 | Data Quality Assurance/Quality Control | 17.6. Data Quality Assurance/Quality Control Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified investigators and appropriate study sites, review of protocol procedures with the investigator and study-site personnel before the study, and periodic monitoring visits by the... | [] |
NCT03201965 | 17.7 | Record Retention | 17.7. Record Retention In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all eCRF and all source documents that support the data collected from each subject, as well as all study documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical Trial, and... | [] |
NCT03201965 | 17.8 | Monitoring | 17.8. Monitoring The sponsor will perform remote monitoring during the safety run-in and randomization phases, and on-site monitoring visits as frequently as necessary. The monitor will record dates of the visits in a study site visit log that will be kept at the study site. The first post-initiation visit will be made... | [] |
NCT03201965 | 17.9 | Study Completion/Termination | 17.9. Study Completion/Termination | [] |
NCT03201965 | 17.9.1 | Study Completion/End of Study | 17.9.1. Study Completion/End of Study The end of the study is defined to be 5 years after the last subject is randomized. The final data from the study sites will be sent to the sponsor (or designee) after completion of the final subject visit at that study site, in the time frame specified in the Clinical Trial Agreem... | [] |
NCT03201965 | 17.9.2 | Study Termination | 17.9.2. Study Termination The sponsor reserves the right to close the study site or terminate the study at any time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A study site is considered closed when all required documents and study supplies have been collected... | [] |
NCT03201965 | 17.10 | On-Site Audits | 17.10. On-Site Audits Representatives of the sponsor's clinical quality assurance department may visit the study site at any time during or after completion of the study to conduct an audit of the study in compliance with regulatory guidelines and company policy. These audits will require access to all study records, i... | [] |
NCT03201965 | 17.11 | Use of Information and Publication | 17.11. Use of Information and Publication All information, including but not limited to information regarding daratumumab or the sponsor's operations (eg, patent application, formulas, manufacturing processes, basic scientific data, prior clinical data, formulation information) supplied by the sponsor to the investigat... | [
"Registration of Clinical Studies and Disclosure of Results",
"REFERENCES",
"ATTACHMENT 1: ECOG PERFORMANCE STATUS SCALE",
"ATTACHMENT 2: DEFINITION OF ORGAN INVOLVEMENT BASED ON AMYLOIDOSIS CONSENSUS CRITERIA",
"ATTACHMENT 3: NYHA CLASSIFICATION",
"ATTACHMENT 4: CONVERSION TABLE FOR GLUCOCORTICOID DOSE",... |
NCT03224325 | 1.0 | STUDY SUMMARY | 1.0 STUDY SUMMARY | Name of Sponsor: | Compound: | |---------------------------------------------------------------------------------------|-------------| | Takeda Development Center Americas, Inc.One Takeda ParkwayDeerfield, IL 60015 | TAK-831 | | Study Identifier: TAK-831-1005 | Phase:1 | Protocol Title: A Randomized... | [
"Trial Design:",
"Trial Primary Objective:",
"Secondary Objectives:",
"Main Criteria for Inclusion for Healthy Subjects:",
"Main Criteria for Exclusion for Healthy Subjects:",
"Additional Exclusion Criteria for Cohort(s) with CSF Collection:",
"Main Criteria for Evaluation and Analyses:",
"Primary End... |
NCT03224325 | 1.1 | Protocol Amendment No. 02 Summary of Changes | 1.1 Protocol Amendment No. 02 Summary of Changes
Rationale for Amendment No. 02 This document describes the changes in reference to the protocol incorporating Amendment No. 02. The primary reason for this amendment is to revise the study procedures to enable cohorts that obtain measurements as described in the previou... | [
"Rationale for Amendment No. 02",
"Changes in Amendment No. 02"
] |
NCT03224325 | 2.0 | STUDY SCHEMATIC | 2.0 STUDY SCHEMATIC | Cohorts | Pretreatment Period | | | Treatment and Assessments (a) | | | | |----------------|---------------------|-----------|-----------|-------------------------------|-----------|------------------|--------| | (up to 6 as | | Check-in/ | | SD Part | | | Follow | | needed) | Screening | Baseline... | [] |
NCT03224325 | 3.0 | SCHEDULE OF STUDY PROCEDURES | 3.0 SCHEDULE OF STUDY PROCEDURES | | Screen-ing | Check in / BaselineAssessments | | Treatment Day | | | | | | | | | | | | StudyExit (a) | | Followup | | | | |-----------------------------------------------------------|--------------------|--------------------------------------------------------------------------------... | [
"PD/BIOMARKER EVALUATIONS"
] |
NCT03224325 | 4.0 | INTRODUCTION | 4.0 INTRODUCTION | [] |
NCT03224325 | 4.1 | Background | 4.1 Background Inhibition of D-amino acid oxidase (DAO) has been proposed as a potential for the treatment of schizophrenia. DAO is a peroxisomal enzyme active toward neutral D-amino acids, which is expressed in both the periphery and the brain. DAO degrades D-amino acids by oxidation. In the periphery, this action lik... | [] |
NCT03224325 | 4.2 | Rationale for the Proposed Study | 4.2 Rationale for the Proposed Study TAK-831 is a highly selective and potent inhibitor of DAO. TAK-831 was shown to increase D-serine levels in the cerebellum of normal rats, and it also demonstrated a positive effect on cognition and social interaction in rodent cognition and behavioral models. TAK-831 is under devel... | [] |
NCT03224325 | 4.3 | Benefit/Risk Profile | 4.3 Benefit/Risk Profile There is no benefit to subjects in this clinical study. The following risk mitigation measures will be implemented in this study with TAK-831. These measures are based on what is known about the mechanism of action of TAK-831, nonclinical data, and the 2 phase 1 studies conducted to date. Proce... | [] |
NCT03224325 | 5.0 | TRIAL OBJECTIVES AND ENDPOINTS | 5.0 TRIAL OBJECTIVES AND ENDPOINTS | [] |
NCT03224325 | 5.1 | Trial Objectives | 5.1 Trial Objectives | [] |
NCT03224325 | 5.1.1 | Trial Primary Objective | 5.1.1 Trial Primary Objective To evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy subjects. | [] |
NCT03224325 | 5.1.2 | Trial Secondary Objective | 5.1.2 Trial Secondary Objective To evaluate the PK of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy subjects. | [] |
NCT03224325 | 5.1.3 | Trial Exploratory Objectives | 5.1.3 Trial Exploratory Objectives  | [] |
NCT03224325 | 5.2 | Endpoints | 5.2 Endpoints | [] |
NCT03224325 | 5.2.1 | Primary Endpoints | 5.2.1 Primary Endpoints Primary endpoints are the safety parameters of TAK-831 and will be assessed as follows: - 1. Percentage of subjects who experience at least 1 treatment-emergent adverse event (TEAE) - 2. Percentage of subjects who meet the markedly abnormal criteria for safety laboratory tests at least once post... | [] |
NCT03224325 | 5.2.2 | Secondary Endpoints | 5.2.2 Secondary Endpoints Secondary endpoints are the plasma PK parameters of TAK-831 and will be measured as follows: - 1. Maximum observed plasma concentration (Cmax) (Day 1). - 2. Maximum observed steady-state plasma concentration during a dosing interval (Day 16). - 3. Time of first occurrence of Cmax (Days 1 and 1... | [] |
NCT03224325 | 6.0 | TRIAL DESIGN AND DESCRIPTION | 6.0 TRIAL DESIGN AND DESCRIPTION | [] |
NCT03224325 | 6.1 | Trial Design | 6.1 Trial Design The study is an investigator and subject blinded, sponsor unblinded, placebo-controlled clinical study progressively assessing independent cohorts of healthy subjects to continue evaluation of the safety, tolerability, and PK of escalating single doses (SD) and multiple doses (MD) of TAK-831, as either... | [] |
NCT03224325 | 6.2 | Dose Escalation | 6.2 Dose Escalation In Cohort 1, the proposed starting dose is TAK-831 600 mg QD, administered as a tablet formulation (Formulation T2) and, in Cohort 2, the starting dose is TAK-831 800 mg QD administered as a suspension formulation. Cohort 1 and Cohort 2 will run in parallel. The proposed dose and dose escalation is ... | [] |
NCT03224325 | 6.3 | Rationale for Trial Design, Dose, and Endpoints | 6.3 Rationale for Trial Design, Dose, and Endpoints | [] |
NCT03224325 | 6.3.1 | Rationale of Trial Design | 6.3.1 Rationale of Trial Design In addition to assessing safety, tolerability, and PK of TAK-831, the proposed study is aimed at providing information on the relationship between concentrations of TAK-831 and to be explored in both plasma and CSF in healthy subjects in order to support dose selection for the follow-up ... | [] |
NCT03224325 | 6.3.2 | Rationale for Dose | 6.3.2 Rationale for Dose Based on the results of toxicology studies, the monkey is considered the more sensitive species. The NOAEL in the 13-week repeat dose study was based on adverse findings of vomiting, diarrhea, and loose stool at the top dose of 600 mg/kg/day. Therefore, the next lower dose tested, 100 mg/kg/day... | [] |
NCT03224325 | 6.3.3 | Rationale for Endpoints | 6.3.3 Rationale for Endpoints | [] |
NCT03224325 | 6.3.3.1 | Primary Endpoint | 6.3.3.1 Primary Endpoint The primary endpoint for this trial is the composite of safety variables to determine the safety and tolerability of oral multiple doses of TAK-831, and dose-limiting effects of TAK-831 and are common for this type of study. | [] |
NCT03224325 | 6.3.3.2 | Secondary Endpoint | 6.3.3.2 Secondary Endpoint The secondary endpoints consist of standard plasma PK variables to determine drug exposure at each dose to facilitate dose escalation. | [] |
NCT03224325 | 6.3.3.3 | Exploratory Endpoints | 6.3.3.3 Exploratory Endpoints (a) Margins relative to Day 14 exposures in humans administered 400 mg/day.  | [] |
NCT03224325 | 6.3.4 | Critical Procedures Based on Trial Objectives: Timing of Procedures | 6.3.4 Critical Procedures Based on Trial Objectives: Timing of Procedures For this trial, collecting safety data and collecting blood in all cohorts and CSF samples in one or more cohorts for TAK-831 PK and PD are the critical procedures. - ! At any postdose time point, safety data need should be collected as close to ... | [] |
NCT03224325 | 6.4 | Trial Design/Dosing/Procedures Modifications Permitted Within Protocol Parameters | 6.4 Trial Design/Dosing/Procedures Modifications Permitted Within Protocol Parameters This is a phase 1 assessment of TAK-831 in healthy subjects. The PK, PD, and safety profiles of the compound are still being elucidated. This protocol is written with some flexibility to accommodate the inherent dynamic nature of phas... | [] |
NCT03224325 | 6.5 | Trial Beginning and End/Completion | 6.5 Trial Beginning and End/Completion | [] |
NCT03224325 | 6.5.1 | Definition of Beginning of the Trial | 6.5.1 Definition of Beginning of the Trial The overall trial begins when the first subject signs the trial informed consent form. | [] |
NCT03224325 | 6.5.2 | Definition of End of the Trial | 6.5.2 Definition of End of the Trial The overall trial ends when the last subject completes the last planned or Follow-up Visit/interaction associated with a planned visit (this can be a phone contact), discontinues from the trial, or is lost to follow-up (ie, the investigator is unable to contact the subject); or dosi... | [] |
NCT03224325 | 6.5.3 | Definition of Trial Completion | 6.5.3 Definition of Trial Completion The primary objective of this phase 1 trial is to identify safety and tolerability of multiple rising doses. Therefore, it is possible that not all planned doses to be administered, if this objective is achieved at lower dose levels in this trial. This is not considered an early ter... | [] |
NCT03224325 | 6.5.4 | Definition of Trial Discontinuation | 6.5.4 Definition of Trial Discontinuation Trial discontinuation because of nonsafety reasons, such as: - A finding (eg, PK, PD, efficacy, biologic targets) from another nonclinical or clinical trial using the trial treatment(s) results in the trial being stopped for a non–safety-related reason. - Data from comparator(s... | [] |
NCT03224325 | 6.5.5 | Criteria for Premature Termination or Suspension of the Trial | 6.5.5 Criteria for Premature Termination or Suspension of the Trial | [] |
NCT03224325 | 6.5.5.1 | Criteria for Premature Termination or Suspension of Trial | 6.5.5.1 Criteria for Premature Termination or Suspension of Trial The study will be completed as planned unless 1 or more of the following criteria are satisfied that require temporary suspension or early termination of the study. - New information or other evaluation regarding the safety or efficacy of the study medic... | [] |
NCT03224325 | 6.5.6 | Criteria for Premature Termination or Suspension of a Site | 6.5.6 Criteria for Premature Termination or Suspension of a Site A trial site may be terminated prematurely or suspended if the site (including the investigator) is found in significant violation of GCP, protocol, or contractual agreement, is unable to ensure adequate performance of the trial, or as otherwise permitted... | [] |
NCT03224325 | 6.5.7 | Procedures for Premature Termination or Suspension of the Study or a Site | 6.5.7 Procedures for Premature Termination or Suspension of the Study or a Site If the sponsor, an IRB, or regulatory authority elects to terminate or suspend the trial or the participation of an investigational site, a trial-specific procedure for early termination or suspension will be provided by the sponsor; the pr... | [] |
NCT03224325 | 7.0 | SELECTION AND DISCONTINUATION/WITHDRAWAL OF SUBJECTS | 7.0 SELECTION AND DISCONTINUATION/WITHDRAWAL OF SUBJECTS All entry criteria, including test results, need to be confirmed before the first dose. | [] |
NCT03224325 | 7.1 | Inclusion Criteria | 7.1 Inclusion Criteria Subject eligibility is determined according to the following criteria before entry into the study: - 1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. - 2. The subject or, when applicable, the subject's legally acceptable repr... | [] |
NCT03224325 | 7.2 | Exclusion Criteria | 7.2 Exclusion Criteria Any subject who meets any of the following criteria will not qualify for entry into the study: - 1. The subject has received any investigational compound within 4 weeks before Screening Visit. The 4-week window will be derived from the date of the last trial procedure and/or AE related to the tri... | [] |
NCT03224325 | 7.2.1 | Additional Exclusion Criteria for Cohort(s) With CSF Collection | 7.2.1 Additional Exclusion Criteria for Cohort(s) With CSF Collection Any subject who meets any of the following criteria will not qualify for entry into the study: - 1. The subject has had CSF collection performed within 30 days before Check-in. - 2. The subject has a known hypersensitivity to the anesthetic or its de... | [] |
NCT03224325 | 7.3 | Excluded Medications, Supplements, Dietary Products | 7.3 Excluded Medications, Supplements, Dietary Products Use of the agents in [Table 7.a](#page-31-1) (prescription or nonprescription) is prohibited from the time points specified until subject is discharged from the unit. Table 7.a Prohibited Medications, Supplements, and Dietary Products | 28 Days Before Check-in | 7... | [] |
NCT03224325 | 7.4 | Diet, Fluid, Activity | 7.4 Diet, Fluid, Activity | [] |
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