Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants
2022年1月20日 更新者:Cerevel Therapeutics, LLC
A Randomized, 3-Period Crossover Trial to Evaluate the Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Adult Participants
This is a Phase 1, single-center trial in healthy participants.
This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.
研究概览
详细说明
The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Arizona
-
Tempe、Arizona、美国、85283
- Celerion Inc.
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Women of nonchildbearing potential and men, ages 18 to 55 years, inclusive.
- Healthy as determined by medical evaluation by the investigator.
- Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs).
- A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use contraception.
- Capable of giving signed informed consent and complying with study requirements.
Exclusion Criteria:
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease.
- Serious risk of suicide in the opinion of the investigator.
- History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
- Any condition that could possibly affect drug absorption.
Receipt of SARS-CoV2 vaccine or booster as follows:
- mRNA: within 14 days prior to dosing
- Non-mRNA: within 28 days prior to dosing
- Have recently been diagnosed with symptomatic COVID-19 or test positive for COVID-19 within 30 days prior to signing the ICF.
- Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
- History of HIV, hepatitis B, or hepatitis C infection, or positive result for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
- Positive drug screen (including nicotine and cannabinoids) or a positive test for alcohol.
- Abnormal clinical laboratory test results or vital measurements at Screening.
- Any other abnormal safety findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the participant or the interpretation of the trial results.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fasted (Without Food)
Oral Dose
|
Tablets
|
实验性的:Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fed (With food)
Oral Dose
|
Tablets
|
实验性的:Single Oral Dose of 25 mg administered as 2 x 7.5 and 2 x 5.0 mg tablets, Fasted (Without Food)
Oral Dose
|
Tablets
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Single Dose: Peak Plasma Concentrations
大体时间:Day 1 to Day 4
|
Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
Single Dose: Area under the plasma concentration-time curve
大体时间:Day 1 to Day 4
|
Area under the plasma concentration-time curve (AUC) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
Single Dose: Area under the plasma concentration-time curve from time zero to last concentration measured
大体时间:Day 1 to Day 4
|
Area under the plasma concentration-time curve from time zero to last concentration measured (AUClast) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
Single Dose: Time of Maximum Observed Plasma Concentrations
大体时间:Day 1 to Day 4
|
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
Secondary Objective: Single Dose: Peak Plasma Concentrations
大体时间:Day 1 to Day 4
|
Peak Plasma Concentration (Cmax) for Darigabat under fed and fasted conditions
|
Day 1 to Day 4
|
Secondary Objective: Single Dose: Area under the plasma concentration-time curve
大体时间:Day 1 to Day 4
|
Area under the plasma concentration-time curve (AUC) for Darigabat under fed and fasted conditions
|
Day 1 to Day 4
|
Secondary Objective: Single Dose: Area under the plasma concentration-time curve from time zero to infinity
大体时间:Day 1 to Day 4
|
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-865 under fed and fasted conditions
|
Day 1 to Day 4
|
Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations
大体时间:Day 1 to Day 4
|
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted and fed conditions
|
Day 1 to Day 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Secondary Outcome (AE)
大体时间:Day 1 to Day 4
|
Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
|
Day 1 to Day 4
|
Secondary Outcome (ECGs)
大体时间:Day 1 to Day 4
|
Number of subjects with clinically significant changes in Electrocardiograms.
|
Day 1 to Day 4
|
Secondary Outcome (Labs)
大体时间:Day 1 to Day 4
|
Number of subjects with clinically significant changes in laboratory measures.
|
Day 1 to Day 4
|
Secondary Outcome (Vital Signs)
大体时间:Day 1 to Day 4
|
Number of subjects with clinically meaningful changes in vitals signs.
|
Day 1 to Day 4
|
Secondary Outcome (Physical/Neurological Exam)
大体时间:Day 1 to Day 4
|
Number of subjects with clinically significant changes in physical and neurological exams.
|
Day 1 to Day 4
|
Secondary Outcome (C-SSRS)
大体时间:Day 1 to Day 4
|
Changes from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS).
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide.
C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
|
Day 1 to Day 4
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Ann M Dandurand, MD、Cerevel Therapeutics, LLC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年11月2日
初级完成 (实际的)
2021年11月21日
研究完成 (实际的)
2021年12月7日
研究注册日期
首次提交
2021年11月5日
首先提交符合 QC 标准的
2021年11月5日
首次发布 (实际的)
2021年11月17日
研究记录更新
最后更新发布 (实际的)
2022年1月21日
上次提交的符合 QC 标准的更新
2022年1月20日
最后验证
2022年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.