A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.
- •Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for <10 years.
- •BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.
排除标准
- •Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.
- •Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.
- •History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.
- •Any significant acute or chronic medical illness.
- •History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent
- •Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A: SAD
SAD = Single Ascending Dose
干预措施: BMS-986172 (Drug)
Part A: SAD
SAD = Single Ascending Dose
干预措施: Placebo (Other)
Part B: MAD
MAD = Multiple Ascending Dose
干预措施: BMS-986172 (Drug)
Part B: MAD
MAD = Multiple Ascending Dose
干预措施: Placebo (Other)
Part C: JMAD
JMAD= Japanese Multiple Ascending Dose
干预措施: BMS-986172 (Drug)
Part C: JMAD
JMAD= Japanese Multiple Ascending Dose
干预措施: Placebo (Other)
Part D: FE/BA
FE/BA = Food Effect/Relative Bioavailability
干预措施: BMS-986172 (Drug)
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 35 days
Incidence of clinically significant changes in physical examination
时间窗: Up to 28 days
Incidence of AEs leading to discontinuation of study treatment
时间窗: Up to 35 days
Incidence of clinically significant changes in clinical laboratory values: Serology tests
时间窗: Up to 28 days
Incidence of non-serious Adverse Events (AEs)
时间窗: Up to 35 days
Incidence of clinically significant changes in vital signs: Heart rate
时间窗: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
时间窗: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
时间窗: Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate
时间窗: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
时间窗: Up to 28 days
Incidence of clinically significant changes in vital signs: Body temperature
时间窗: Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure
时间窗: Up to 28 days
Incidence of clinically significant changes in ECG parameters: QTcF
时间窗: Up to 28 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
次要结局
- Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))(Up to 28 days)
- Plasma concentrations of BMS-986172(Up to 28 days)
- Maximum observed plasma concentration (Cmax)(Up to 28 days)