Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
- Registration Number
- NCT02705989
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 439
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiple Ascending Dose(MAD) Placebo Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 Single Ascending Dose (SAD) Placebo Single ascending dose of BMS-986195 or Placebo matching BMS-986195 Japanese-Multiple Ascending Dose(MAD) Placebo Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage Single Ascending Dose (SAD) BMS-986195 Single ascending dose of BMS-986195 or Placebo matching BMS-986195 Japanese-Multiple Ascending Dose(MAD) BMS-986195 Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage Multiple Ascending Dose(MAD) BMS-986195 Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 Relative Bioavailability with Food Effects (Open Label) BMS-986195 -
- Primary Outcome Measures
Name Time Method 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 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 Up to 21 days during and after last dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇦🇺Melbourne, Victoria, Australia