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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705989
• Other study ID #: IM014-001
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2016
• Est. completion date: August 16, 2017

Study information

• Verified date: January 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BMS-986195
Specified dose on specified day

Other:
• Placebo
Specified dose on specified day

Locations

Country	Name	City	State
Australia	Local Institution	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form