Healthy Participants
Conditions
Keywords
Healthy participants, BMS-986196
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 BMS-986196 absorption will be performed.
Interventions
DRUGBMS-986196
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| 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 |
Countries
United States
Outcome results
None listed