Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: BMS-986195; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02705989

IM014-001

Details and patient eligibility

About

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.

Enrollment: 439 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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439 participants in 4 patient groups, including a placebo group

Single Ascending Dose (SAD)

Placebo Comparator group

Description:

Single ascending dose of BMS-986195 or Placebo matching BMS-986195

Treatment:

Other: Placebo

Drug: BMS-986195

Multiple Ascending Dose(MAD)

Placebo Comparator group

Description:

Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195

Treatment:

Other: Placebo

Drug: BMS-986195

Japanese-Multiple Ascending Dose(MAD)

Placebo Comparator group

Description:

Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage

Treatment:

Other: Placebo

Drug: BMS-986195

Relative Bioavailability with Food Effects (Open Label)

Experimental group

Treatment:

Drug: BMS-986195