A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption
- Registration Number
- NCT04926051
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B: MAD Placebo MAD = Multiple Ascending Dose Part C: JMAD Placebo JMAD= Japanese Multiple Ascending Dose Part A: SAD BMS-986172 SAD = Single Ascending Dose Part D: FE/BA BMS-986172 FE/BA = Food Effect/Relative Bioavailability Part A: SAD Placebo SAD = Single Ascending Dose Part B: MAD BMS-986172 MAD = Multiple Ascending Dose Part C: JMAD BMS-986172 JMAD= Japanese Multiple Ascending Dose
- Primary Outcome Measures
Name Time Method Incidence of clinically significant changes in physical examination Up to 28 days Incidence of clinically significant changes in clinical laboratory values: Serology tests Up to 28 days Incidence of clinically significant changes in vital signs: Heart rate Up to 28 days Incidence of clinically significant changes in clinical laboratory values: Hematology tests Up to 28 days Incidence of clinically significant changes in clinical laboratory values: Chemistry tests Up to 28 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 28 days Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests Up to 28 days Incidence of clinically significant changes in vital signs: Body temperature Up to 28 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 28 days Incidence of clinically significant changes in ECG parameters: QTcF 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
Incidence of Serious Adverse Events (SAEs) Up to 35 days Incidence of AEs leading to discontinuation of study treatment Up to 35 days Incidence of non-serious Adverse Events (AEs) Up to 35 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
ICON Plc (Legacy PRA)
🇺🇸Lenexa, Kansas, United States
ICON Plc (Legacy PRA)🇺🇸Lenexa, Kansas, United States