Clinical trial NCT02705989: Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 8 days during and after last dose
measure: 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
timeFrame: Up to 21 days during and after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: