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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo; Drug: BMS-986196

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Local Institution - 0002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: SAD; SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.	Other: Placebo; Specified dose on specified days; Drug: BMS-986196; Specified dose on specified days
Experimental: Part B: MAD; MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.	Other: Placebo; Specified dose on specified days; Drug: BMS-986196; Specified dose on specified days
Experimental: 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.	Drug: BMS-986196; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Up to 24 days
Severity of AEs	Up to 24 days
Causality of AEs	Up to 24 days
Incidence of Serious Adverse Events (SAEs)	Up to 59 days
Severity of SAEs	Up to 59 days
Causality of SAEs	Up to 59 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: Blood pressure	Up to 24 days
Incidence of clinically significant changes in vital signs: Heart rate	Up to 24 days
Incidence of clinically significant changes in weight	Up to 24 days
Incidence of clinically significant changes in physical examination	Up to 24 days
Incidence of clinically significant changes in ECG parameters: QT interval	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
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests	Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Coagulation tests	Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests	Up to 24 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Healthy participants; BMS-986196
• Other Study ID Numbers: IM038-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No