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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02705989
• Date of registration: 07/03/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
• Scientific 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
• Date of first enrolment: August 18, 2016
• Target sample size: 439
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02705989
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Other: Placebo

Drug: BMS-986195

Primary Outcome(s)

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]

Secondary ID(s)

IM014-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors