protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03085758 | 12.3 | Subject Insurance | 12.3 Subject Insurance Insurance for patients included in this study will be arranged by ADRENOMED AG as sponsor of the clinical study according to country-specific requirements. A copy of the insurance certification will be held in the study master file at ADRENOMED AG. Patients are to be informed by the investigator ... | [] |
NCT03085758 | 12.4 | Steering Committee | 12.4 Steering Committee The Steering Committee oversees all aspects of the study and during the study will remain blinded to treatment group results. The Steering Committee has the authority to propose protocol amendments to the sponsor based on its monitoring of the progress of the study, including reports or recommen... | [] |
NCT03085758 | 12.5 | Data and Safety Monitoring Board | 12.5 Data and Safety Monitoring Board The Data and Safety Monitoring Board (DSMB) will be established and serves as an independent group responsible for the ongoing review of a clinical trial and for making recommendations to the sponsor concerning the continuation, modification, and termination of the trial throughout... | [] |
NCT03085758 | 13 | ADMINISTRATIVE STRUCTURE AND RESPONSIBILITIES | 13. ADMINISTRATIVE STRUCTURE AND RESPONSIBILITIES | [] |
NCT03085758 | 13.1 | Study Monitoring | 13.1 Study Monitoring This study will be monitored according to the monitoring plan which will be prepared and filed in the study master file prior to initiation of a study site. The monitor is responsible for routine review of the eCRFs at regular intervals throughout the trial to verify adherence to the protocol and ... | [] |
NCT03085758 | 13.2 | Investigator Study File | 13.2 Investigator Study File The investigator is responsible for keeping files of essential documents as defined by the ICH guidelines on GCP and local requirements. The Investigator's Study File must be available at monitoring visits and during an audit or inspection. | [] |
NCT03085758 | 13.3 | Changes in Study Conduct | 13.3 Changes in Study Conduct For any change of the study conduct the sponsor must be contacted and must agree to such change. Substantial changes to the protocol during the study will be documented as protocol amendments. The amended protocol will be signed by the responsible personnel at ADRENOMED AG and the Principa... | [] |
NCT03085758 | 13.4 | Protocol Compliance | 13.4 Protocol Compliance The Investigator is responsible for ensuring the study is conducted in accordance with the procedures and evaluations described in this protocol. | [] |
NCT03085758 | 13.5 | Protocol Deviations | 13.5 Protocol Deviations Sponsor does not allow any deviations or exemptions relating to protocol inclusion and exclusion criteria. All protocol deviations will be documented. This study will be conducted as described in this protocol except for emergency situations in which the protection, safety, and well-being of th... | [] |
NCT03085758 | 13.6 | Drug Accountability | 13.6 Drug Accountability The investigator or designee (i.e., pharmacist) is responsible for ensuring adequate accountability of all used and unused investigational medicinal product and placebo. This includes acknowledgement of receipt of each shipment of IMP kits (quantity and condition), IMP administration records, a... | [] |
NCT03085758 | 13.7 | Audits and Inspections | 13.7 Audits and Inspections The investigator will permit study-related audits, and inspections by the IRB/IEC, the sponsor, and regulatory authorities of all study-related documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.). The investigator will ensure the availability... | [] |
NCT03085758 | 13.8 | Confidentiality | 13.8 Confidentiality The investigators, designated CRO and ADRENOMED AG and all other involved parties will preserve the confidentiality of all patients taking part in the study, in accordance with ICH-GCP and local regulations. The confidentiality of all patient identities will be maintained, except during source data... | [] |
NCT03085758 | 13.9 | Patient Data and Data Protection | 13.9 Patient Data and Data Protection Permission for direct access to patient data will be sought in writing by the investigator and from the patient as part of the informed consent procedure. This gives permission to examine, analyse, verify and reproduce any records and reports that are important to the evaluation of... | [] |
NCT03085758 | 13.10 | Reports | 13.10 Reports All reports to the sponsor will be written in English. All clinical, analytical and statistical results will be presented in a final clinical study report which will be structured in accordance with ICH Topic E3. The clinical study report will be the sole property of the sponsor. Publication of the clinic... | [] |
NCT03085758 | 13.11 | Publication of Study Results | 13.11 Publication of Study Results The investigator and the institution recognize that all data generated from this study are the proprietary and confidential information of the sponsor, along with all information supplied by the sponsor. The sponsor recognizes the investigator's and the institution's rights and obliga... | [] |
NCT03085758 | 13.12 | Study Documents and Record Retention | 13.12 Study Documents and Record Retention The investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be significantly verified. These documents should be classified into two separate categories (although not limited to) the following: (1... | [] |
NCT03085758 | 13.13 | Data Archiving | 13.13 Data Archiving The clinical center is responsible for the secure and restrictive archiving of source data for at least 15 years or until written notification from ADRENOMED AG that the documents are no longer required. During the required period, the clinical center will ensure that archived data and documents wi... | [] |
NCT03085758 | 14 | REFERENCES | 14. REFERENCES 1) Blet et al.; Hemodynamics effects of adrecizumab in sepsis rat. Intensive Care Medicine Experimental 2015, 3 (Suppl 1): A618 - 2) Caironi P. et al.; Albumin Replacement in Patients with Severe Sepsis or Septic Shock. NEJM 370:1412 – 1421, 2014 - 3) Dellinger R. P. et al.; Surviving Sepsis Campaign: In... | [
"APPENDICES",
"Appendix 1: Declaration of Sponsor and Investigator",
"DECLARATION OF SPONSOR",
"Appendix 2: APACHE II Score",
"A. Acute Physiology Score:",
"APACHE II Severity of Disease Classification System",
"Appendix 3: SOFA Score",
"Appendix 4: IMP Body weight Adjustment",
"IMP Bodyweight Adjus... |
NCT03101293 | 1.0 | ADMINISTRATIVE INFORMATION | 1.0 ADMINISTRATIVE INFORMATION | [] |
NCT03101293 | 1.1 | Contacts | 1.1 Contacts A separate contact information list will be provided to each site. | Takeda Development Center Americas, Inc. | |------------------------------------------| | | | | | | | [] |
NCT03101293 | 1.2 | Approval | 1.2 Approval
REPRESENTATIVES OF TAKEDA This study will be conducted with the highest respect for the individual participants in accordance with the requirements of this clinical study protocol and also in accordance with the following: - ! The ethical principles that have their origin in the Declaration of Helsinki. -... | [
"REPRESENTATIVES OF TAKEDA",
"SIGNATURES"
] |
NCT03101293 | 1.3 | Protocol Amendment 01 Summary of Changes | 1.3 Protocol Amendment 01 Summary of Changes
Rationale for Amendment No. 01 This document describes the changes in reference to the Protocol Incorporating Amendment No. 01. The primary purpose of this amendment is to update the protocol regarding additional ECG time points at the expected Cmax of the TAK-831 tablet, t... | [
"Rationale for Amendment No. 01",
"Changes in Amendment No. 1",
"INVESTIGATOR AGREEMENT"
] |
NCT03101293 | 2.0 | STUDY SUMMARY | 2.0 STUDY SUMMARY | Name of Sponsor: | Compound: | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------... | [
"Study Design:",
"Primary Objectives",
"Secondary Objective",
"Main Criteria for Inclusion:",
"Main Criteria for Exclusion:",
"Main Criteria for Evaluation and Analyses:",
"Primary Endpoints:",
"Secondary Endpoints",
"Statistical Considerations:",
"PK:",
"Safety:"
] |
NCT03101293 | 3.0 | STUDY REFERENCE INFORMATION | 3.0 STUDY REFERENCE INFORMATION | [] |
NCT03101293 | 3.1 | Study-Related Responsibilities | 3.1 Study-Related Responsibilities The sponsor will perform all study-related activities with the exception of those identified in the Study-Related Responsibilities template. The vendors identified for specific study-related activities will perform these activities in full or in partnership with the sponsor. | 3.2 | P... | [] |
NCT03101293 | 3.3 | List of Abbreviations | 3.3 List of Abbreviations Term Definition %CV percent coefficient of variation AE adverse event ALT alanine aminotransferase AST aspartate aminotransferase AUC area under the plasma concentration-time curve AUC∞ area under the plasma concentration-time curve from time 0 to infinity AUClast area under the plasma concent... | [] |
NCT03101293 | 3.4 | Corporate Identification | 3.4 Corporate Identification Takeda Takeda Development Center Americas and Europe | [] |
NCT03101293 | 4.0 | INTRODUCTION | 4.0 INTRODUCTION | [] |
NCT03101293 | 4.1 | Background | 4.1 Background Ataxia manifests as impaired coordination of muscle movements. It is a nonspecific clinical manifestation indicative of dysfunction in the parts of the central nervous system (CNS) that coordinate movement, such as the cerebellum. The cerebellum is one of the key CNS structures responsible for collating ... | [] |
NCT03101293 | 4.2 | Rationale for the Proposed Study | 4.2 Rationale for the Proposed Study A new T2 oral tablet formulation of TAK-831 has been developed and is planned for use in future clinical studies. The purpose of the current study is to characterize the PK of a single 400 mg dose of the TAK-831 T2 tablet formulation (given the stability limitations of the current T... | [] |
NCT03101293 | 5.0 | STUDY OBJECTIVES AND ENDPOINTS | 5.0 STUDY OBJECTIVES AND ENDPOINTS | [] |
NCT03101293 | 5.1 | Objectives | 5.1 Objectives | [] |
NCT03101293 | 5.1.1 | Primary Objectives | 5.1.1 Primary Objectives ! To determine the PK of a single oral dose of TAK-831 400 mg in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as the T2 tablet formulation in healthy subjects. | [] |
NCT03101293 | 5.1.2 | Secondary Objective | 5.1.2 Secondary Objective ! To evaluate the safety and tolerability of a single oral dose of TAK-831 400 mg in healthy subjects in the fed and fasted states. | [] |
NCT03101293 | 5.1.3 | Exploratory Objectives | 5.1.3 Exploratory Objectives | [] |
NCT03101293 | 5.2 | Endpoints | 5.2 Endpoints | [] |
NCT03101293 | 5.2.1 | Primary Endpoints: | 5.2.1 Primary Endpoints: The following PK parameters of TAK-831 derived for each regimen: - ! Maximum observed plasma concentration (Cmax). - ! Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUClast). - ! Area under the plasma concentration-time curve from tim... | [] |
NCT03101293 | 5.2.2 | Secondary Endpoint | 5.2.2 Secondary Endpoint ! Percentage of subjects who experience at least 1 TEAE. | [] |
NCT03101293 | 5.2.3 | Exploratory Endpoints | 5.2.3 Exploratory Endpoints  The following PK parameters for TAK-831 for each regimen: - ! tmax. - ! t1/2z. - ! CL/F. - ! Vz/F.  | [] |
NCT03101293 | 6.0 | STUDY DESIGN AND DESCRIPTION | 6.0 STUDY DESIGN AND DESCRIPTION | [] |
NCT03101293 | 6.1 | Study Design | 6.1 Study Design TAK-831-1004 is a phase 1, randomized, open-label, single-dose, 2-period crossover study designed to characterize the PK of TAK-831 400 mg and assess the effect of food on the bioavailability of TAK-831 400 mg, when administered as four 100 mg oral tablets of the T2 formulation in healthy male and fema... | [] |
NCT03101293 | 6.2 | Justification for Study Design, Dose, and Endpoints | 6.2 Justification for Study Design, Dose, and Endpoints This phase 1 food-effect study is designed in accordance with the Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations Guidance for Industry from the Food and Drug Administration (FDA), the Food-Effect Bioavailability and Fed... | [] |
NCT03101293 | 6.3 | Premature Termination or Suspension of Study or Investigational Site | 6.3 Premature Termination or Suspension of Study or Investigational Site | [] |
NCT03101293 | 6.3.1 | Criteria for Premature Termination or Suspension of the Study | 6.3.1 Criteria for Premature Termination or Suspension of the Study 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 d... | [] |
NCT03101293 | 6.3.2 | Criteria for Premature Termination or Suspension of Investigational Sites | 6.3.2 Criteria for Premature Termination or Suspension of Investigational Sites A study 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 study, or as othe... | [] |
NCT03101293 | 6.3.3 | Procedures for Premature Termination or Suspension of the Study or the Participation of Investigational Site | 6.3.3 Procedures for Premature Termination or Suspension of the Study or the Participation of Investigational Site In the event that the sponsor, an institutional review board (IRB), or regulatory authority elects to terminate or suspend the study or the participation of a study site, a study-specific procedure for ear... | [] |
NCT03101293 | 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 prior to randomization. | [] |
NCT03101293 | 7.1 | Inclusion Criteria | 7.1 Inclusion Criteria Subject eligibility is determined according to the following criteria prior to 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 signs and dates a written, informed consent form and any... | [] |
NCT03101293 | 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 30 days prior to randomization. - 2. The subject has received TAK-831 in a previous clinical study. - 3. The subject is an immediate fam... | [] |
NCT03101293 | 7.3 | Excluded Medications, Supplements, Dietary Products | 7.3 Excluded Medications, Supplements, Dietary Products Use of the agents listed in [Table 7.a](#page-29-1) is prohibited from the time points specified until completion of all study-related activities, including the Follow-up Phone Call. Table 7.a Excluded Medications, Supplements, and Dietary Products | 28 Days Prior... | [] |
NCT03101293 | 7.4 | Diet, Fluid, Activity Control | 7.4 Diet, Fluid, Activity Control Subjects will be confined to the clinic from Check-in (Day -1) through completion of study procedures on Day 3 in each period. During each confinement period, subjects will be served standardized meals (except for Ensure Plus) and an evening snack, each containing ~30% fat (relative to... | [] |
NCT03101293 | 7.5 | Criteria for Discontinuation or Withdrawal of a Subject | 7.5 Criteria for Discontinuation or Withdrawal of a Subject The primary reason for discontinuation or withdrawal of the subject from the study or study drug should be recorded in the eCRF using the following categories. For screen failure subjects, refer to Section [9.1.17.](#page-45-0) - 1. Pretreatment event (PTE) or... | [] |
NCT03101293 | 7.6 | Procedures for Discontinuation or Withdrawal of a Subject | 7.6 Procedures for Discontinuation or Withdrawal of a Subject The investigator may discontinue a subject's study participation at any time during the study when the subject meets the discontinuation criteria described in Section [7.5.](#page-30-0) In addition, a subject may discontinue his or her participation without ... | [] |
NCT03101293 | 8.0 | CLINICAL STUDY MATERIAL MANAGEMENT | 8.0 CLINICAL STUDY MATERIAL MANAGEMENT This section contains information regarding all medications and materials provided directly by the sponsor, and/or sourced by other means, that are required by the study protocol, including important sections describing the management of study material. | [] |
NCT03101293 | 8.1 | Study Drug and Materials | 8.1 Study Drug and Materials | [] |
NCT03101293 | 8.1.1 | Dosage Form, Manufacturing, Packaging, and Labeling | 8.1.1 Dosage Form, Manufacturing, Packaging, and Labeling In this protocol, the term "study drug" refers to all or any of the drugs defined below. | [] |
NCT03101293 | 8.1.1.1 | Study Drug | 8.1.1.1 Study Drug TAK-831 T2 100 mg tablets will be provided as unmarked, yellow-red, film-coated tablets for oral administration. TAK-831 is manufactured by Takeda Pharmaceuticals, Osaka, Japan. The TAK-831 T2 100 mg tablets will be supplied in amber glass bottles with metal screw caps, with each bottle containing 32... | [] |
NCT03101293 | 8.1.1.2 | Ancillary Materials | 8.1.1.2 Ancillary Materials Ensure Plus will be provided by the site. This nutritional drink has a total volume of 237 mL (8 fl oz) and 355 total calories. Of the total calories, 103 calories are from fat (total fat content is 17% of daily value), 201 calories are from carbohydrate (total carbohydrate content is 17% of... | [] |
NCT03101293 | 8.1.1.3 | Sponsor-Supplied Drug | 8.1.1.3 Sponsor-Supplied Drug Sponsor-supplied drugs referenced in other sections of the protocol include the following: TAK-831 T2 100 mg tablets. | [] |
NCT03101293 | 8.1.2 | Storage | 8.1.2 Storage Study drug (TAK-831 T2 100 mg tablets) and ancillary materials (Ensure Plus) must be kept in an appropriate, limited-access, secure place until used or returned to the sponsor or designee for destruction. Study drug must be stored under the conditions specified on the label and remain in the original cont... | [] |
NCT03101293 | 8.1.3 | Dose and Regimen | 8.1.3 Dose and Regimen The study drug supplies for each treatment period are indicated in [Table 8.a.](#page-33-3) Table 8.a Study Drug Supplies per Treatment Period | | Regimen | | | | | | |--------------------|----------|----------|--|--|--|--| | Treatment Sequence | Period 1 | Period 2 | | | | | | 1 | A | B | | | | ... | [] |
NCT03101293 | 8.1.4 | Overdose | 8.1.4 Overdose An overdose is defined as a known deliberate or accidental administration of study drug, to or by a study subject, at a dose above that which is assigned to that individual subject according to the study protocol. All cases of overdose (with or without associated AEs) will be documented on an Overdose pa... | [] |
NCT03101293 | 8.2 | Study Drug Assignment and Dispensing Procedures | 8.2 Study Drug Assignment and Dispensing Procedures Subjects will be assigned, in the order in which they are randomized into the study, to receive their treatment according to the randomization schedule allocated to the site. Subjects will be assigned to receive a 4-digit randomization number. The number will be assig... | [] |
NCT03101293 | 8.3 | Randomization Code Creation and Storage | 8.3 Randomization Code Creation and Storage Randomization personnel of the sponsor or its designee will generate the randomization schedule and will provide it to the site pharmacist prior to the start of this study. All randomization information will be stored in a secured area, accessible only by authorized personnel... | [] |
NCT03101293 | 8.4 | Accountability and Destruction of Sponsor-Supplied Drugs | 8.4 Accountability and Destruction of Sponsor-Supplied Drugs Drug supplies will be counted and reconciled at the site before being returned to the sponsor or designee. The investigator or designee must ensure that the sponsor-supplied drug is used in accordance with the protocol and is dispensed only to subjects enroll... | [] |
NCT03101293 | 9.0 | STUDY PLAN | 9.0 STUDY PLAN | [] |
NCT03101293 | 9.1 | Study Procedures | 9.1 Study Procedures The following sections describe the study procedures to be performed and data to be collected. For each procedure, subjects are to be assessed by the same investigator or site personnel whenever possible. The Schedule of Study Procedures is located in [Appendix](#page-72-0) A. | [] |
NCT03101293 | 9.1.1 | Informed Consent Procedure | 9.1.1 Informed Consent Procedure The requirements of the informed consent are described in Section [15.2.](#page-67-0) Informed consent must be obtained prior to the subject entering into the study, and before any protocol-directed procedures are performed, including requesting that a subject fast for laboratory evalua... | [] |
NCT03101293 | 9.1.1.1 | Pharmacogenomics Informed Consent Procedure | 9.1.1.1 Pharmacogenomics Informed Consent Procedure Pharmacogenomics (PGx) informed consent is a component of the overall study informed consent. The requirements are described in Section [15.2.](#page-67-0) PGx sample collection is mandatory. | [] |
NCT03101293 | 9.1.2 | Demographics, Medical History, and Medication History Procedure | 9.1.2 Demographics, Medical History, and Medication History Procedure Demographics to be obtained will include date of birth, sex, Hispanic ethnicity, race as described by the subject, height, weight, caffeine consumption, xanthine consumption, alcohol use, reproductive status, and smoking status of the subject at Scre... | [] |
NCT03101293 | 9.1.3 | Physical Examination Procedure | 9.1.3 Physical Examination Procedure A baseline physical examination (defined as the assessment prior to the first dose of study drug) will consist of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7... | [] |
NCT03101293 | 9.1.4 | Weight, Height and BMI | 9.1.4 Weight, Height and BMI A subject should have weight and height measured while wearing indoor clothing and with shoes off. The BMI is calculated using metric units with the formula provided below. Height is recorded in centimeters without decimal places and weight is recorded in kilograms (kg) with 1 decimal place... | [] |
NCT03101293 | 9.1.5 | Vital Sign Procedure | 9.1.5 Vital Sign Procedure Vital signs will include oral body temperature, respiratory rate, blood pressure, and heart rate (beats per minute). Blood pressure and heart rate will be measured in 2 positions: after 5 minutes supine and then after 1 and 3 minutes standing. Vital signs should be measured at the same time o... | [] |
NCT03101293 | 9.1.6 | Documentation of Concomitant Medications | 9.1.6 Documentation of Concomitant Medications Concomitant medication is any drug given in addition to the study drug. These may be prescribed by a physician or obtained by the subject over the counter. Concomitant medication is not provided by Takeda. At each study visit, subjects will be asked whether they have taken... | [] |
NCT03101293 | 9.1.7 | Documentation of Concurrent Medical Conditions | 9.1.7 Documentation of Concurrent Medical Conditions Concurrent medical conditions are those significant ongoing conditions or diseases that are present at signing of informed consent. This includes clinically significant laboratory, ECG, or physical examination abnormalities noted at the screening or baseline examinat... | [] |
NCT03101293 | 9.1.8 | Procedures for Clinical Laboratory Samples | 9.1.8 Procedures for Clinical Laboratory Samples All samples will be collected in accordance with acceptable laboratory procedures. Laboratory samples will be collected following an overnight fast of ≥10 hours (except for those collected at Screening) on the days stipulated in the Schedule of Study Procedures in [Appen... | [] |
NCT03101293 | 9.1.9 | Contraception and Pregnancy Avoidance Procedure | 9.1.9 Contraception and Pregnancy Avoidance Procedure | [] |
NCT03101293 | 9.1.9.1 | Male Subjects and Their Female Partners | 9.1.9.1 Male Subjects and Their Female Partners From signing of informed consent, throughout the duration of the study, and for 95 days after the last dose of study drug, nonsterilized\\ male subjects who are sexually active with a female partner of childbearing potential\ must use barrier contraception (eg, condom wit... | [] |
NCT03101293 | 9.1.9.2 | Female Subjects and Their Male Partners | 9.1.9.2 Female Subjects and Their Male Partners Women of childbearing potential will not be included in this study. | [] |
NCT03101293 | 9.1.9.3 | Definitions and Procedures for Contraception and Pregnancy Avoidance The following definitions apply for contraception and pregnancy avoidance procedures. | 9.1.9.3 Definitions and Procedures for Contraception and Pregnancy Avoidance The following definitions apply for contraception and pregnancy avoidance procedures. - \ A woman is considered a woman of childbearing potential, that is, fertile, following menarche and until becoming postmenopausal unless permanently steril... | [] |
NCT03101293 | 9.1.10 | Pregnancy | 9.1.10 Pregnancy Women of childbearing potential will not be included in this study. If any subject is found to be pregnant during the study she should be withdrawn and any sponsor-supplied drug (TAK-831) should be immediately discontinued. In addition, any pregnancies in the female partner of a male subject during the... | [] |
NCT03101293 | 9.1.11 | ECG Procedure | 9.1.11 ECG Procedure Standard 12-lead ECGs will be recorded. When an ECG is scheduled at the same time as the blood draws or vital signs, then the blood draws and vital signs will take priority and the ECG will be obtained within 0.5 hours before or after the scheduled blood draw or vital sign assignment. If an ECG coi... | [] |
NCT03101293 | 9.1.12 | PGx Sample Collection | 9.1.12 PGx Sample Collection DNA forms the basis for the genes that make the body produce proteins such as enzymes, drug transporters, or drug targets, and may be evaluated for the genetic contribution to how the drug is broken down or how the drug affects the body. This is called a "PGx research study." Specific purpo... | [] |
NCT03101293 | 9.1.13 | PK Sample Collection | 9.1.13 PK Sample Collection | [] |
NCT03101293 | 9.1.13.1 | Collection of Blood for PK Sampling | 9.1.13.1 Collection of Blood for PK Sampling Serial blood samples (one 4-mL sample per scheduled time) for PK analysis of TAK-831 will be collected into chilled Vacutainers containing the anticoagulant K2EDTA, according to the schedule shown in [Table](#page-44-4) 9.b. Table 9.b Collection of Blood Samples for PK Analy... | [] |
NCT03101293 | 9.1.13.2 | Bioanalytical Methods | 9.1.13.2 Bioanalytical Methods Plasma concentrations of TAK-831 will be measured by high-performance liquid chromatography with tandem mass spectrometry. | [] |
NCT03101293 | 9.1.14 | PK Parameters | 9.1.14 PK Parameters The plasma PK parameters of TAK-831 will be determined from the plasma concentration-time profiles for all evaluable subjects using noncompartmental analysis. Actual sampling times, rather than scheduled sampling times, will be used in all computations involving sampling times. The plasma PK parame... | [] |
NCT03101293 | 9.1.15 | PD Sample Collection | 9.1.15 PD Sample Collection Serial blood samples (one 6-mL sample per scheduled time) for PD analysis of TAK-831 will be collected into chilled Vacutainers containing the anticoagulant K2EDTA, according to the schedule shown in [Table](#page-45-3) 9.d. Table 9.d Collection of Blood Samples for PD Analysis The actual ti... | [] |
NCT03101293 | 9.1.16 | PD Parameters | 9.1.16 PD Parameters PD parameters will be determined from the concentration-time profiles for all evaluable subjects. Actual sampling times, rather than scheduled sampling times, will be used in all computations involving sampling times.  | [] |
NCT03101293 | 9.1.17 | Documentation of Screen Failure | 9.1.17 Documentation of Screen Failure Investigators must account for all subjects who sign informed consent. If the subject is withdrawn at the Screening Visit, the investigator should complete the screen failure page of the eCRF. The primary reason for screen failure is recorded in the eCRF using the following catego... | [] |
NCT03101293 | 9.1.18 | Documentation of Randomization | 9.1.18 Documentation of Randomization Only subjects who meet all of the inclusion criteria and none of the exclusion criteria are eligible for randomization into the treatment phase. If the subject is found to be not eligible for randomization, the investigator should record the primary reason for failure on the applic... | [] |
NCT03101293 | 9.1.19 | C-SSRS | 9.1.19 C-SSRS The Baseline/Screening C-SSRS will be administered in this study. The C-SSRS was developed by researchers at Columbia University as a tool to help systematically assess suicidal ideation and behavior in subjects during participation in a clinical study of centrally-acting drugs [\[20,](#page-71-5)[21\]](#... | [] |
NCT03101293 | 9.2 | Monitoring Subject Treatment Compliance | 9.2 Monitoring Subject Treatment Compliance Study drug will be administered while subjects are under observation in the clinic. Following administration of the study drug, appropriate mouth and/or hand checks will be performed to ensure that the dose is swallowed and noted in the source document. The date and time of e... | [] |
NCT03101293 | 9.3 | Schedule of Observations and Procedures | 9.3 Schedule of Observations and Procedures The schedule for the study-related procedures to be performed at each visit is shown in [Appendix](#page-72-0) A. Assessments should be completed at the designated visit/time points. | [] |
NCT03101293 | 9.3.1 | Screening | 9.3.1 Screening Subjects will be screened within 28 days prior to administration of the first dose of study drug. Subjects will be screened in accordance with predefined inclusion and exclusion criteria as described in Section [7.0.](#page-26-2) See Section [9.1.17](#page-45-0) for procedures for documenting screen fai... | [] |
NCT03101293 | 9.3.2 | Study Entrance/Randomization | 9.3.2 Study Entrance/Randomization Eligible subjects will be admitted to the clinic on Day -1 (Check-in) of each period. Randomization will occur on Day 1 of Period 1, prior to administration of the first dose of study drug. If the subject has satisfied all of the inclusion criteria and none of the exclusion criteria f... | [] |
NCT03101293 | 9.3.3 | Treatment Periods 1 and 2 | 9.3.3 Treatment Periods 1 and 2 In each period, after administration of the single dose of study drug, subjects will remain confined to the clinic until completion of all study-related procedures on Day 3. Subjects will return to the clinic for study visits on Days 4, 6, and 8. | [] |
NCT03101293 | 9.3.4 | Study Exit | 9.3.4 Study Exit The Final Visit will be performed at Study Exit on Day 8 of Period 2. For all subjects receiving study drug, the investigator must complete the End-of-Study page of the eCRF. | [] |
NCT03101293 | 9.3.5 | Early Termination | 9.3.5 Early Termination The reason for discontinuation must be documented in the source document and eCRF. For all subjects receiving study drug, the investigator must complete the End-of-Study page of the eCRF. | [] |
NCT03101293 | 9.3.6 | Follow-up Visit/Telephone Call | 9.3.6 Follow-up Visit/Telephone Call The Follow-up Visit will occur by telephone on Study Day 23±2 and will be for the purpose of assessing AEs and inquiring about concomitant medications taken since Study Exit. If the subject displayed abnormal, clinically significant observations at Study Exit, the subject may be bro... | [] |
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