A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety and Tolerability, and Pharmacokinetics (Including Food Effect, pH Effect and Japanese Bridging Study) of BMS-986337 Following Oral Administration in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
- •Body mass index (BMI) of 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening; BMI = weight (kg)/height (m)^2
- •Women and men must agree to follow specific methods of contraception, if applicable
排除标准
- •Women who are of childbearing potential
- •Women who are breastfeeding
- •Prior exposure to BMS-986278
- •Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part B MAD Cohort B3
干预措施: BMS-986337 Placebo (Other)
Part A Single Ascending Dose (SAD) Cohort A1
干预措施: BMS-986337 (Drug)
Part A Single Ascending Dose (SAD) Cohort A1
干预措施: BMS-986337 Placebo (Other)
Part A SAD Cohort A2
干预措施: BMS-986337 (Drug)
Part A SAD Cohort A2
干预措施: BMS-986337 Placebo (Other)
Part A SAD Cohort A3
干预措施: BMS-986337 (Drug)
Part A SAD Cohort A3
干预措施: BMS-986337 Placebo (Other)
Part A SAD Cohort A4
干预措施: BMS-986337 (Drug)
Part A SAD Cohort A4
干预措施: BMS-986337 Placebo (Other)
Part A SAD Cohort A5
干预措施: BMS-986337 (Drug)
Part A SAD Cohort A5
干预措施: BMS-986337 Placebo (Other)
Part A SAD Cohort A6
干预措施: BMS-986337 (Drug)
Part A SAD Cohort A6
干预措施: Famotidine (Biological)
Part B Multiple Ascending Dose (MAD) Cohort B1
干预措施: BMS-986337 (Drug)
Part B Multiple Ascending Dose (MAD) Cohort B1
干预措施: BMS-986337 Placebo (Other)
Part B MAD Cohort B2
干预措施: BMS-986337 (Drug)
Part B MAD Cohort B2
干预措施: BMS-986337 Placebo (Other)
Part B MAD Cohort B3
干预措施: BMS-986337 (Drug)
Part B MAD Cohort B4
干预措施: BMS-986337 (Drug)
Part B MAD Cohort B4
干预措施: BMS-986337 Placebo (Other)
Part C MAD in Japanese Healthy participants Cohort C1
干预措施: BMS-986337 (Drug)
Part C MAD in Japanese Healthy participants Cohort C1
干预措施: BMS-986337 Placebo (Other)
Part C MAD in Japanese Healthy participants Cohort C2
干预措施: BMS-986337 (Drug)
Part C MAD in Japanese Healthy participants Cohort C2
干预措施: BMS-986337 Placebo (Other)
Part C MAD in Japanese Healthy participants Cohort C3
干预措施: BMS-986337 (Drug)
Part C MAD in Japanese Healthy participants Cohort C3
干预措施: BMS-986337 Placebo (Other)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 30 days
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 81 days
Incidence of AEs leading to discontinuation
时间窗: Up to 30 days
Number of clinically significant changes in clinical laboratory values: Urinalysis tests
时间窗: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Hematology tests
时间窗: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
时间窗: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
时间窗: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
时间窗: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Blood Pressure
时间窗: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
时间窗: Up to 51 days
Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
时间窗: Up to 51 days
Number of clinically significant changes in ECG parameters: QRS duration
时间窗: Up to 51 days
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Number of clinically significant changes from baseline in physical examinations
时间窗: Up to 51 days
Number of clinically significant changes in ECG parameters: PR interval
时间窗: Up to 51 days
PR interval is the time from the onset of the P wave to the start of the QRS complex
Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)
时间窗: Up to 51 days
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.
Number of clinically significant changes in ECG parameters: QT interval
时间窗: Up to 51 days
The QT interval is the time from the start of the Q wave to the end of the T wave.
次要结局
未报告次要终点