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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 10, 2022

Interventions

  • Drug: BMS-986196
    • Specified dose on specified days
  • Other: Placebo
    • Specified dose on specified days

Arms, Groups and Cohorts

  • Experimental: Part A: SAD
    • SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.
  • Experimental: Part B: MAD
    • MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Adverse Events (AEs)
    • Time Frame: Up to 24 days
  • Severity of AEs
    • Time Frame: Up to 24 days
  • Causality of AEs
    • Time Frame: Up to 24 days
  • Incidence of Serious Adverse Events (SAEs)
    • Time Frame: Up to 59 days
  • Severity of SAEs
    • Time Frame: Up to 59 days
  • Causality of SAEs
    • Time Frame: Up to 59 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: Blood pressure
    • 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 weight
    • Time Frame: Up to 24 days
  • Incidence of clinically significant changes in physical examination
    • 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 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
  • 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 clinical laboratory values: Urinalysis tests
    • Time Frame: Up to 24 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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