A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
- Registration Number
- NCT04882150
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
- Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
- Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg
Exclusion Criteria
- Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Presence of any factors that would predispose the participant to develop infection
- A history of bacterial or fungal meningitis within 1 year prior to screening
- A history of intracranial or intraspinal bleeding
- Known intracranial space-occupying mass, including meningioma
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: MAD Placebo MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo. Part A: SAD BMS-986196 SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo. Part A: SAD Placebo SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo. Part B: MAD BMS-986196 MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo. Part C: FE/Formul. BMS-986196 FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food.
- Primary Outcome Measures
Name Time Method Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests Up to 24 days Incidence of clinically significant changes in weight Up to 24 days Severity of AEs Up to 24 days Incidence of clinically significant changes in vital signs: Body temperature Up to 24 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 24 days Incidence of clinically significant changes in vital signs: Heart rate Up to 24 days Incidence of clinically significant changes in ECG parameters: QT interval Up to 24 days Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests Up to 24 days Causality of AEs Up to 24 days Severity of SAEs Up to 59 days Incidence of Serious Adverse Events (SAEs) Up to 59 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 24 days Incidence of clinically significant changes in physical examination Up to 24 days Incidence of Adverse Events (AEs) Up to 24 days Causality of SAEs Up to 59 days Incidence of clinically significant changes in clinical laboratory values: Coagulation tests Up to 24 days Incidence of clinically significant changes in ECG parameters: HR Up to 24 days Incidence of clinically significant changes in clinical laboratory values: Hematology tests Up to 24 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution - 0002
🇺🇸Salt Lake City, Utah, United States