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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882150
• Other study ID #: IM038-008
• Status: Completed
• Phase: Phase 1
• Start date: May 27, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: January 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986196
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0002	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 24 days
Primary	Severity of AEs		Up to 24 days
Primary	Causality of AEs		Up to 24 days
Primary	Incidence of Serious Adverse Events (SAEs)		Up to 59 days
Primary	Severity of SAEs		Up to 59 days
Primary	Causality of SAEs		Up to 59 days
Primary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 24 days
Primary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 24 days
Primary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 24 days
Primary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 24 days
Primary	Incidence of clinically significant changes in weight		Up to 24 days
Primary	Incidence of clinically significant changes in physical examination		Up to 24 days
Primary	Incidence of clinically significant changes in ECG parameters: QT interval		Up to 24 days
Primary	Incidence of clinically significant changes in ECG parameters: HR		Up to 24 days
Primary	Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 24 days
Primary	Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests		Up to 24 days
Primary	Incidence of clinically significant changes in clinical laboratory values: Coagulation tests		Up to 24 days
Primary	Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 24 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting