A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- BMS-986195
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 439
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of single oral dose of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in healthy subjects, and to assess the relative bioavailability of two formulations of BMS-986195 with or without food.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body Mass Index(BMI) of 18 to 32 kilograms/meter\^2
- •Healthy male and female, first generation Japanese with confirmed paternal and maternal Japanese ancestry, 18-55 years old, whose residency outside of Japan does not exceed 10 years with a BMI of 18-30 kilograms/meter\^2 inclusive.
- •Women must not be pregnant or breastfeeding
- •Women of Childbearing Potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required.
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required.
Exclusion Criteria
- •Any significant acute or chronic medical illness
- •Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosis, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (example: history of splenectomy)
- •Presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of preexisting skin conditions that increase risks for injection site complications e.g. Behcet's Disease, Psoriasis, pustular dermatoses
- •Any history or risk for tuberculosis (TB)
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
Single Ascending Dose (SAD)
Single ascending dose of BMS-986195 or Placebo matching BMS-986195
Intervention: BMS-986195
Single Ascending Dose (SAD)
Single ascending dose of BMS-986195 or Placebo matching BMS-986195
Intervention: Placebo
Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195
Intervention: BMS-986195
Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195
Intervention: Placebo
Japanese-Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
Intervention: BMS-986195
Japanese-Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
Intervention: Placebo
Relative Bioavailability with Food Effects (Open Label)
Intervention: BMS-986195
Outcomes
Primary Outcomes
Safety and tolerability of single oral dose of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Time Frame: Up to 8 days during and after last dose
Safety and tolerability of multiple oral doses of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Time Frame: Up to 21 days during and after last dose