Status:
COMPLETED
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04882150
Start Date
May 27 2021
End Date
June 10 2022
Last Update
January 12 2023
Active Locations (1)
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1
Local Institution - 0002
Salt Lake City, Utah, United States, 84124