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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02705989
• Collaborator: (none)
• Enrollment: 439
• Location: 1
• Arms: 4
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 36.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: BMS-986195; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 439 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 18, 2016
• Actual Primary Completion Date: Aug 16, 2017
• Actual Study Completion Date: Aug 16, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Single Ascending Dose (SAD) Single ascending dose of BMS-986195 or Placebo matching BMS-986195	Drug: BMS-986195; Specified dose on specified day; Other: Placebo; Specified dose on specified day
Placebo Comparator: Multiple Ascending Dose(MAD) Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195	Drug: BMS-986195; Specified dose on specified day; Other: Placebo; Specified dose on specified day
Placebo Comparator: Japanese-Multiple Ascending Dose(MAD) Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage	Drug: BMS-986195; Specified dose on specified day; Other: Placebo; Specified dose on specified day
Experimental: Relative Bioavailability with Food Effects (Open Label)	Drug: BMS-986195; Specified dose on specified day

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02705989
• Other Study ID Numbers: IM014-001
• First Posted: Mar 11, 2016
• Last Update Posted: Jan 30, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Branebrutinib

Study Results

No Results Posted as of Jan 30, 2019