protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05059600 | 13.3 | General Considerations | 13.3. General Considerations For the purpose of all primary and secondary analyses where applicable, baseline is defined as the last measurement prior to initiation of the ZULRESSO infusion. Continuous endpoints will be summarized with number (n), mean, standard deviation, median, minimum, and maximum. In addition, cha... | [] |
NCT05059600 | 13.4 | Demographics and Baseline Characteristics | 13.4. Demographics and Baseline Characteristics Demographic data, such as age, race, and ethnicity, and baseline characteristics (eg, weight), will be summarized using the Safety Set. Pregnancy test results will be listed but not summarized. Medical history will be listed by participant. | [] |
NCT05059600 | 13.5 | Efficacy Analysis | 13.5. Efficacy Analysis Not applicable | [] |
NCT05059600 | 13.6 | Safety Analyses | 13.6. Safety Analyses Safety data collected in this study (ie, AEs, concomitant medication usage, changes from baseline in vital signs, nonadherence with safe-use conditions with administration of ZULRESSO, and ) will be listed by participant and summarized. All safety summaries will be performed on the Safety Set usin... | [] |
NCT05059600 | 13.6.1 | Adverse Events | 13.6.1. Adverse Events Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 24.0 or higher. A TEAE is defined as an AE with onset after the start of IP. The analysis of AEs will be based on the concept of TEAEs. The incidence of TEAEs will be summarized by System Organ Class ... | [] |
NCT05059600 | 13.6.2 | Vital Signs | 13.6.2. Vital Signs Vital sign results at each visit and mean changes from baseline will be summarized by scheduled visit. Potentially clinically significant values will be summarized. Vital sign results will be listed by participant and timing of collection. | [] |
NCT05059600 | 13.6.3 | Oxygen Saturation | 13.6.3. Oxygen Saturation Oxygen saturation results at baseline and results recorded for any event of excessive sedation, loss of consciousness, hypoxia or AESI, if applicable, will be summarized. Oxygen saturation results, if applicable, will be listed by participant and timing of collection. | [] |
NCT05059600 | 13.6.5 | Nonadherence with Safe-use Administration of ZULRESSO | 13.6.5. Nonadherence with Safe-use Administration of ZULRESSO The incidence of nonadherence with safe-use administration of ZULRESSO will be summarized. | [] |
NCT05059600 | 13.6.6 | Use-related Issues Related to the Home Administration of ZULRESSO | 13.6.6. Use-related Issues Related to the Home Administration of ZULRESSO Use-related issues of ZULRESSO will be summarized. | [] |
NCT05059600 | 13.6.7 | Medication Error | 13.6.7. Medication Error The incidence of medication error will be summarized. | [] |
NCT05059600 | 13.6.9 | Prior and Concomitant Medications | 13.6.9. Prior and Concomitant Medications Medications will be recorded throughout the duration of the study and may be coded using World Health Organization-Drug dictionary Global B3 March 2020, or later. Medications taken prior to the initiation of the start of IP will be denoted "Prior". Those medications taken prior... | [] |
NCT05059600 | 13.6.10 | Other Safety Analysis | 13.6.10. Other Safety Analysis Analysis of use-related issues and home healthcare provider comprehension of and compliance to processes and procedures will be described in the SAP. | [] |
NCT05059600 | 13.7 | Clinical Pharmacology Analyses | 13.7. Clinical Pharmacology Analyses Not applicable. | [] |
NCT05059600 | 13.8 | Sample Size and Power | 13.8. Sample Size and Power The sample size is based on assuming a 7% incidence rate of TEAEs leading to IP discontinuation or interruption, which is the rate observed in the post-marketing setting. With 50 participants who receive ZULRESSO, the probability is 0.87 for observing at least 2 events; 0.69 for observing at... | [] |
NCT05059600 | 13.8.1 | Interim and Data Monitoring Committee Analyses | 13.8.1. Interim and Data Monitoring Committee Analyses Not applicable. | [] |
NCT05059600 | 14 | DIRECT ACCESS TO SOURCE DATA/DOCUMENTS | 14. DIRECT ACCESS TO SOURCE DATA/DOCUMENTS | [] |
NCT05059600 | 14.1 | Study Monitoring | 14.1. Study Monitoring Before an investigational site can enter a participant into the study, a representative of Sage Therapeutics will remotely assess the investigational study site per Sage SOPs to determine suitability of the investigator to oversee the clinical study and discuss with the investigator(s) and other ... | [] |
NCT05059600 | 14.2 | Audits and Inspections | 14.2. Audits and Inspections Sage Therapeutics or authorized representatives of Sage Therapeutics, a regulatory authority, or an IEC or an IRB may visit the site to perform an audit(s) or inspection(s). The purpose of a Sage Therapeutics audit or a regulatory authority inspection is to systematically and independently ... | [] |
NCT05059600 | 14.3 | Institutional Review Board or Ethics Committee | 14.3. Institutional Review Board or Ethics Committee The Principal Investigator must obtain IRB (or IEC) approval for the clinical study prior to enrolling a participant. Initial IRB (or IEC) approval, and all materials approved by the IRB (or IEC) for this study including the participant consent form and recruitment m... | [] |
NCT05059600 | 15 | QUALITY CONTROL AND QUALITY ASSURANCE | 15. QUALITY CONTROL AND QUALITY ASSURANCE To ensure compliance with GCP and all applicable regulatory requirements, Sage Therapeutics may conduct a quality assurance audit(s) at the clinical site. Please see Section 14.2 for more details regarding the audit process. The investigator must have adequate quality control p... | [] |
NCT05059600 | 16 | ETHICS | 16. ETHICS | [] |
NCT05059600 | 16.1 | Ethics Review | 16.1. Ethics Review The final study protocol, including the final version of the Informed Consent Form, must be given a written and dated approval or favorable opinion by an IRB or IEC as appropriate. The investigator must obtain and document approval before he or she can enroll any participant into the study. The IRB ... | [] |
NCT05059600 | 16.2 | Ethical Conduct of the Study | 16.2. Ethical Conduct of the Study The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH and GCP guidelines, as well as all applicable regional or national regulatory requirements. | [] |
NCT05059600 | 16.3 | Informed Consent Process | 16.3. Informed Consent Process The informed consent process for this study will be conducted by telephone/videoconference using electronic informed consent technology. Prior to enrolling a study participant, the investigator(s) will ensure that the participant is given full and adequate oral and written/electronic info... | [] |
NCT05059600 | 17 | DATA HANDLING AND RECORDKEEPING | 17. DATA HANDLING AND RECORDKEEPING | [] |
NCT05059600 | 17.1 | Inspection of Records | 17.1. Inspection of Records Sage Therapeutics or its representative(s) will be allowed to conduct site visits at the investigation facilities for the purpose of monitoring any aspect of the study. The investigator agrees to allow the monitor to inspect the facility, drug storage area, drug accountability records, parti... | [] |
NCT05059600 | 17.2 | Retention of Records | 17.2. Retention of Records The Principal Investigator must maintain all documentation relating to the study for the period outlined in the site contract, or for a period of 2 years after the last marketing application approval, and until there are no pending or contemplated marketing applications in an ICH region or at... | [] |
NCT05059600 | 18 | PUBLICATION POLICY | 18. PUBLICATION POLICY All information concerning ZULRESSO is considered confidential and shall remain the sole property of Sage Therapeutics. The investigator agrees to use this information only in conducting the study and shall not use it for any other purposes without written approval from Sage Therapeutics. No publ... | [] |
NCT05059600 | 19 | LIST OF REFERENCES | 19. LIST OF REFERENCES Bauman BL, Ko JY, Cox S, et al. Vital signs: Postpartum depressive symptoms and provider discussions about perinatal depression – United States 2018. MMWR Morb Moral Wkly Rep. 2020;69(19):575-581. Bloch M, Schmidt PJ, Danaceau M, et al. Effects of gonadal steroids in women with a history of postp... | [
"Protocol 547-PPD-404, Amendment 1",
"Assessment of Safe-Use Conditions for Administration of ZULRESSO in a Home Setting",
"Rationale for Protocol Amendment"
] |
NCT05098054 | 1.0 | STUDY SUMMARY | 1.0 STUDY SUMMARY | Name of Sponsor: | Compound: | | |---------------------------------------------------------|-----------------------|--| | Takeda Development Center Americas, Inc. (TDC Americas) | Soticlestat (TAK-935) | | | 95 Hayden Avenue | | | | Lexington, MA 02421 | | | | Telephone: +1 (617) 679-7000 | | | | St... | [
"Study Design:",
"Study Primary Objective:",
"Study Secondary Objective:",
"Criteria for Inclusion:",
"Inclusion for Participants with Hepatic Impairment",
"Inclusion for Healthy Participants",
"Inclusion for Participants with Hepatic Impairment and Healthy Participants Heal",
"Criteria for Exclusion:... |
NCT05098054 | 2.0 | STUDY SCHEMATIC | 2.0 STUDY SCHEMATIC Table 2.a Study Design for Arms 1, 2, and 3 | Screening | Check-in andPredoseAssessments a | Soticlestat Dosing,PK Sampling andStudyAssessments | PK Samplingand StudyAssessments | PK Sampling, StudyAssessments and StudyDischargeb | msTerFollow-upble | |-----------------------------------------------... | [] |
NCT05098054 | 3.0 | SCHEDULE OF STUDY PROCEDURES | 3.0 SCHEDULE OF STUDY PROCEDURES | Soticlestat (TAK-935) | | | | | | | | | | | | | | | | | | | | | fo | eUs | | |-----------------------------------------|--------|----------|--------|-------|------|--------|--------------|---|------|--------------------------------|----|-----|----|---------|----|----------|------|----... | [] |
NCT05098054 | 4.0 | INTRODUCTION | 4.0 INTRODUCTION | [] |
NCT05098054 | 4.1 | Background | 4.1 Background | [] |
NCT05098054 | 4.1.1 | Soticlestat (TAK-935) | 4.1.1 Soticlestat (TAK-935) Soticlestat is a potent and selective cholesterol 24S hydroxylase (CH24H) inhibitor currently in development as an oral adjunct to standard of care therapy for the treatment of rare pediatric epilepsies referred to as Developmental and Epileptic Encephalopathies (DEE) which are a cluster of ... | [] |
NCT05098054 | 4.1.1.2 | Clinical Safety and Pharmacokinetics | 4.1.1.2 Clinical Safety and Pharmacokinetics The PK, safety, tolerability, and/or efficacy of soticlestat have been evaluated in 6 phase 1 clinical studies in healthy participants (completed), a phase 1b/2a study in participants with DEEs (completed), and 3 phase 2 studies in participants with DS, LGS, 15q11-q13 duplic... | [] |
NCT05098054 | 4.2 | Rationale for the Proposed Study onale | 4.2 Rationale for the Proposed Study onale In this study, the impact of HI on the PK of single dose soticlestat . After entering the body, drugs are eliminated by excretion and/or metabolism. Although elimination can occur through a variety of routes, most drugs are cleared by metabolism in the liver and/or small intes... | [] |
NCT05098054 | 4.3 | Benefit/Risk Profile | 4.3 Benefit/Risk Profile The single dose of 300 mg soticlestat has been selected for this study as it is the recommended phase 3 dose [1]. In addition, doses up to 1350 mg were administered in healthy participants and were found to be safe and well tolerated. The inclusion and exclusion criteria, screening, and safety ... | [] |
NCT05098054 | 5.0 | STUDY OBJECTIVES AND ENDPOINTS | 5.0 STUDY OBJECTIVES AND ENDPOINTS | [] |
NCT05098054 | 5.1 | Hypothesis | 5.1 Hypothesis Not applicable. | [] |
NCT05098054 | 5.2 | Study Objectives | 5.2 Study Objectives | [] |
NCT05098054 | 5.2.1 | Study Primary Objective | 5.2.1 Study Primary Objective To characterize the plasma PK of soticlestat following a single oral dose in participants with moderate or mild HI compared to matched healthy participants with normal hepatic function. derate | [] |
NCT05098054 | 5.2.2 | Study Secondary Objective | 5.2.2 Study Secondary Objective To evaluate the safety and tolerability of soticlestat following a single oral dose in participants safet | [] |
NCT05098054 | 5.3 | Endpoints | 5.3 Endpoints | [] |
NCT05098054 | 5.3.1 | Primary Endpoints | 5.3.1 Primary Endpoints The following PK parameters in plasma will be analyzed for soticlestat: - Cmax - AUC∞ - AUClast | [] |
NCT05098054 | 5.3.2 | Secondary Endpoints | 5.3.2 Secondary Endpoints - Incidence of TEAEs - Incidence of clinically significant abnormal values for laboratory evaluations, vital signs, ECG parameters, and C-SSRS laboratory  | [] |
NCT05098054 | 6.0 | STUDY DESIGN AND DESCRIPTION | 6.0 STUDY DESIGN AND DESCRIPTION | [] |
NCT05098054 | 6.1 | Study Design | 6.1 Study Design This is a phase 1, open-label, study of oral soticlestat designed to assess the PK of single dose soticlestat in participants with moderate or mild HI compared to matched healthy participants with normal hepatic function. At least 12 healthy participants (up to 24 participants) with normal hepatic func... | [] |
NCT05098054 | 6.2 | Dose Escalation | 6.2 Dose Escalation Not applicable. | [] |
NCT05098054 | 6.3 | Stopping Rules | 6.3 Stopping Rules Not applicable. | [] |
NCT05098054 | 6.4 | Rationale for Study Design, Dose, and Endpoints | 6.4 Rationale for Study Design, Dose, and Endpoints | [] |
NCT05098054 | 6.4.1 | Rationale of Study Design | 6.4.1 Rationale of Study Design After entering the body, drugs are eliminated by excretion and/or metabolism. Although elimination can occur through a variety of routes, most drugs are cleared by metabolism in the liver and/or small intestine and/or by elimination of unchanged drug by the kidneys. Liver disease is asso... | [] |
NCT05098054 | 6.4.2 | Rationale for Dose | 6.4.2 Rationale for Dose T4 tablets are immediate release tablets of 100 mg strength that will be utilized for phase 3 clinical studies and will be used in this study. The model simulation (SimCYP®) predicted increase in soticlestat exposure in participants with moderate or mild HI is within two-fold, therefore the dos... | [] |
NCT05098054 | 6.4.3 | Rationale for Endpoints | 6.4.3 Rationale for Endpoints | [] |
NCT05098054 | 6.4.3.1 | Pharmacokinetic Endpoints | 6.4.3.1 Pharmacokinetic Endpoints The PK endpoints are standard for this type of study. | [] |
NCT05098054 | 6.4.3.2 | Safety Endpoints | 6.4.3.2 Safety Endpoints The key safety endpoints are typical for phase 1 studies and will be assessed through monitoring of AEs, vital signs, ECGs, laboratory assessments, C-SSRS, and physical examinations. SSRS, examinat  | [] |
NCT05098054 | 6.4.5 | Critical Procedures Based on Study Objectives: Timing of Procedures | 6.4.5 Critical Procedures Based on Study Objectives: Timing of Procedures For this study, the critical component is the blood collection for plasma concentrations of soticlestat , and is to be collected within the sampling windows. thi | [] |
NCT05098054 | 6.5 | Study Design/Dosing/Procedures Modifications Permitted Within Protocol Parameters | 6.5 Study Design/Dosing/Procedures Modifications Permitted Within Protocol Parameters The dose and administration of soticlestat for all participants with moderate HI, mild HI, and healthy participants with normal hepatic function (ie, Arms 1, 2, and 3) may not be modified. After all participants in the moderate HI arm... | [] |
NCT05098054 | 6.6 | Study Beginning and End/Completion | 6.6 Study Beginning and End/Completion | [] |
NCT05098054 | 6.6.1 | Definition of Beginning of the Study | 6.6.1 Definition of Beginning of the Study The beginning of the study will be defined as the beginning of the screening (ie, signing of the ICF) of the first participant. | [] |
NCT05098054 | 6.6.2 | Definition of End of the Study | 6.6.2 Definition of End of the Study The end of study is defined as the date of the last scheduled study procedure as outlined in the Schedule of Study Procedures (Section 3.0) s study | [] |
NCT05098054 | 6.6.3 | Definition of Study Completion | 6.6.3 Definition of Study Completion The end of the study is scheduled after completion of the evaluations in the follow-up visit for the last participant in the study. complet This time period may change in the event that the study is terminated early or the last participant is lost to follow-up. ime | [] |
NCT05098054 | 6.6.4 | Definition of Study Discontinuation | 6.6.4 Definition of Study Discontinuation The clinical site(s) reserve(s) the right to terminate the study in the interest of participant welfare. The Sponsor reserves the right to suspend or terminate the study at any time. study study | [] |
NCT05098054 | 6.6.5 | Criteria for Premature Termination or Suspension of the Study | 6.6.5 Criteria for Premature Termination or Suspension of the Study The study will be completed as planned unless one or more of the following criteria are satisfied that require temporary suspension or early termination of the study: study temporary New information or other evaluation regarding the safety or efficacy ... | [] |
NCT05098054 | 6.6.6 | Criteria for Premature Termination or Suspension of a Site | 6.6.6 Criteria for Premature Termination or Suspension of a Site | [] |
NCT05098054 | 6.6.6.1 | Criteria for Premature Termination or Suspension | 6.6.6.1 Criteria for Premature Termination or Suspension A study site may be terminated prematurely or suspended if the site (including the Investigator) is found in significant violation of GCP, the study protocol, or contractual agreement; if the site (including the Investigator) is unable to ensure adequate performa... | [] |
NCT05098054 | 6.6.6.2 | Procedures for Premature Termination or Suspension | 6.6.6.2 Procedures for Premature Termination or Suspension In the event that the sponsor, an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), or a regulatory authority elects to terminate or suspend the participation of an investigational site, a study-specific procedure for early termination or sus... | [] |
NCT05098054 | 7.0 | SELECTION AND DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS TINUATION/WITHDRAWAL | 7.0 SELECTION AND DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS TINUATION/WITHDRAWAL | [] |
NCT05098054 | 7.1 | Inclusion Criteria | 7.1 Inclusion Criteria | [] |
NCT05098054 | 7.1.1 | Inclusion for Participants with Hepatic Impairment | 7.1.1 Inclusion for Participants with Hepatic Impairment Participants must fulfill the following inclusion criteria to be eligible for participation in the study (participants who do not qualify based on a reversible condition or mild intercurrent illness may be re-screened after the condition is resolved. Screening te... | [] |
NCT05098054 | 7.1.2 | Inclusion for Healthy Participants | 7.1.2 Inclusion for Healthy Participants Participants must fulfill the following inclusion criteria to be eligible for participation in the study: - 1. Is an adult male or female participant aged ≥ 18 to < 75 years, at screening. Healthy participants will be matched to hepatic impaired participants in this study by sex... | [] |
NCT05098054 | 7.1.3 | Inclusion for Participants with Hepatic Impairment and Healthy Participants | 7.1.3 Inclusion for Participants with Hepatic Impairment and Healthy Participants Participants must fulfill the following inclusion criteria to be eligible for participation in the study: pants f - 1. Understands the study procedures in the ICF, provides a signature/date in the ICF, and is willing and able to comply wi... | [] |
NCT05098054 | 7.2 | Exclusion Criteria | 7.2 Exclusion Criteria | [] |
NCT05098054 | 7.2.1 | Exclusion for Participants with Hepatic Impairment | 7.2.1 Exclusion for Participants with Hepatic Impairment The participant must be excluded from participating in the study if the participant: - 1. Has history or presence of clinically significant medical or psychiatric condition or disease (aside from HI) or presence of psychotic disorders such as psychosis, delusions... | [] |
NCT05098054 | 7.2.2 | Exclusion for Healthy Participants | 7.2.2 Exclusion for Healthy Participants The participant must be excluded from participating in the study if the participant: - 1. Has history or presence of clinically significant medical or psychiatric condition or disease or presence of psychotic disorders such as psychosis, delusions, or schizophrenia in the opinio... | [] |
NCT05098054 | 7.2.3 | Exclusion for Participants with Hepatic Impairment and Healthy Participants | 7.2.3 Exclusion for Participants with Hepatic Impairment and Healthy Participants The participant must be excluded from participating in the study if the participant: ust from - 1. Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additi... | [] |
NCT05098054 | 7.3 | Excluded Medications, Supplements, Dietary Products | 7.3 Excluded Medications, Supplements, Dietary Products Healthy participants will be restricted of using any prescription medications/products and any over-the-counter, nonprescription preparations (including herbal products, natural or herbal supplements) from at least 14 days before dosing and throughout the study. H... | [] |
NCT05098054 | 7.4 | Diet, Fluid, Activity | 7.4 Diet, Fluid, Activity | [] |
NCT05098054 | 7.4.1 | Diet and Fluid | 7.4.1 Diet and Fluid Water (except water provided with dosing) will be restricted 1 hour prior to and 1 hour after dosing, but will be allowed ad libitum at all other times, when dosing occurs at the CRU. Other fluids may be given as part of meals and snacks but will be restricted at all other times throughout the conf... | [] |
NCT05098054 | 7.4.2 | Activity | 7.4.2 Activity All participants will remain seated for the first 4 hours following dosing, except when they are supine or semi-reclined for study procedures. Participants will then resume normal activity. ll act However, should AEs occur at any time, participants may be placed in an appropriate position or will be perm... | [] |
NCT05098054 | 7.5 | Criteria for Discontinuation or Withdrawal of a Participant | 7.5 Criteria for Discontinuation or Withdrawal of a Participant The primary reason for discontinuation or withdrawal of the participant from the study or study drug should be recorded in the case report form (CRF) using the following categories. inuation wi rep 1. Pretreatment event (PTE) or AE: The participant has exp... | [
"Liver Function Test (LFT) Abnormalities Abnormalit",
"QTcF interval:"
] |
NCT05098054 | 7.6 | Procedures for Discontinuation or Withdrawal of a Participant Discontinuat | 7.6 Procedures for Discontinuation or Withdrawal of a Participant Discontinuat The Investigator may discontinue a participant's study participation at any time during the study when the participant meets the study termination criteria described in Section 7.5. In addition, a participant may discontinue his or her parti... | [] |
NCT05098054 | 7.7 | Participant Replacement | 7.7 Participant Replacement Replacement of discontinued or withdrawn participants due to any reason will be assessed on a case by case basis by the sponsor and Investigator. Any participant who is not PK evaluable including those experiencing emesis within 8 hours post dose may be replaced at the discretion of the Inve... | [] |
NCT05098054 | 8.0 | CLINICAL STUDY MATERIAL MANAGEMENT | 8.0 CLINICAL STUDY MATERIAL MANAGEMENT | [] |
NCT05098054 | 8.1 | Clinical Study Drug | 8.1 Clinical Study Drug
Investigational Medicinal Product Product Name: Soticlestat (TAK-935) Strength: 100 mg Dose: 300 mg, 3 x 100mg Dosage Form/Formulation: T4 immediate-release tablet Dosing regimen: Single dose Route of Administration: Oral | [
"Investigational Medicinal Product"
] |
NCT05098054 | 8.1.1 | Clinical Study Drug Labeling | 8.1.1 Clinical Study Drug Labeling Study drug containers will be affixed with a clinical label in accordance with local regulatory requirements. wit wit | [] |
NCT05098054 | 8.1.2 | Clinical Study Drug Inventory and Storage | 8.1.2 Clinical Study Drug Inventory and Storage The same lot number will be used throughout the study. The lot numbers and expiration dates (where available) of the study drug supplied will be recorded in the final report. Study drugs will be stored according to the product labels provided with the product. Property of... | [] |
NCT05098054 | 8.1.3 | Clinical Study Drug Blinding | 8.1.3 Clinical Study Drug Blinding This is an open-label study. open label study | [] |
NCT05098054 | 8.1.4 | Randomization Code Creation and Storage | 8.1.4 Randomization Code Creation and Storage Not applicable. | [] |
NCT05098054 | 8.1.5 | Clinical Study Blind Maintenance/Unblinding Procedure | 8.1.5 Clinical Study Blind Maintenance/Unblinding Procedure Not applicable. | [] |
NCT05098054 | 8.1.6 | Accountability and Destruction of Sponsor-Supplied Drugs | 8.1.6 Accountability and Destruction of Sponsor-Supplied Drugs Records will be made of the receipt and dispensing of the study drugs supplied. At the conclusion of the study, any unused soticlestat will be retained by Celerion/clinical sites, as applicable, returned to the Sponsor or designee, or destroyed, as per Spon... | [] |
NCT05098054 | 9.0 | STUDY PROCEDURES | 9.0 STUDY PROCEDURES | [] |
NCT05098054 | 9.1 | Administrative Procedures | 9.1 Administrative Procedures | [] |
NCT05098054 | 9.1.1 | Informed Consent Procedure | 9.1.1 Informed Consent Procedure The purpose of the study, the procedures to be carried out and the potential hazards will be described to the participants in non-technical terms. Participants will be required to read, sign, and date an ICF summarizing the discussion prior to screening, and will be assured that they ma... | [] |
NCT05098054 | 9.1.1.1 | Assignment of Screening and Identification Numbers | 9.1.1.1 Assignment of Screening and Identification Numbers Each participant will be assigned a unique identification number upon screening. Participants who complete the study screening assessments and meet all the eligibility criteria will be assigned a unique identification number at the time of dosing, different fro... | [] |
NCT05098054 | 9.1.1.2 | Study Drug Assignment | 9.1.1.2 Study Drug Assignment All participants will receive the treatments as detailed in Section 9.2.8. Sect | [] |
NCT05098054 | 9.1.2 | Inclusion and Exclusion | 9.1.2 Inclusion and Exclusion Please refer to Section 7.1 and Section 7.2. ase | [] |
NCT05098054 | 9.1.3 | Medical History/Demography History/ | 9.1.3 Medical History/Demography History/ Medical history and demographic data, including name, sex, age, race, ethnicity, history of tobacco use, and Child-Pugh classification will be recorded. dem Child | [] |
NCT05098054 | 9.1.4 | Concomitant Medications | 9.1.4 Concomitant Medications Concomitant medications will be prohibited as listed in Section 7.3. All medications taken by participants during the course of the study will be recorded. medicat parti | [] |
NCT05098054 | 9.2 | Clinical Procedures and Assessments | 9.2 Clinical Procedures and Assessments The Schedule of Study Procedures (Section 3.0) summarizes the clinical procedures to be performed at each visit. Individual clinical procedures are described in detail below. Additional evaluations/testing may be deemed necessary by the Investigator or designee and/or the Sponsor... | [] |
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