A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986196; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882150

IM038-008

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups

Part A: SAD

Experimental group

Description:

SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.

Treatment:

Drug: BMS-986196

Other: Placebo

Part B: MAD

Experimental group

Description:

MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.

Treatment:

Drug: BMS-986196

Other: Placebo

Part C: FE/Formul.

Experimental group

Description:

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.

Treatment:

Drug: BMS-986196