A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986196 in Healthy Participants Including an Open-label Assessment of Food and Formulation Effects on the Relative Bioavailability of BMS-986196
Overview
- Phase
- Phase 1
- Intervention
- BMS-986196
- Conditions
- Healthy Participants
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Severity of AEs
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Part A: SAD
SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.
Intervention: BMS-986196
Part A: SAD
SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.
Intervention: Placebo
Part B: MAD
MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.
Intervention: BMS-986196
Part B: MAD
MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.
Intervention: Placebo
Part C: FE/Formul.
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.
Intervention: BMS-986196
Outcomes
Primary Outcomes
Severity of AEs
Time Frame: Up to 24 days
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame: Up to 24 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to 24 days
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame: Up to 24 days
Incidence of clinically significant changes in ECG parameters: QT interval
Time Frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time Frame: Up to 24 days
Causality of AEs
Time Frame: Up to 24 days
Severity of SAEs
Time Frame: Up to 59 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 59 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame: Up to 24 days
Incidence of clinically significant changes in physical examination
Time Frame: Up to 24 days
Incidence of Adverse Events (AEs)
Time Frame: Up to 24 days
Causality of SAEs
Time Frame: Up to 59 days
Incidence of clinically significant changes in weight
Time Frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time Frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Coagulation tests
Time Frame: Up to 24 days
Incidence of clinically significant changes in ECG parameters: HR
Time Frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame: Up to 24 days