NCT02705989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

August 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

March 7, 2016

Last Update Submit

January 28, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

Single Ascending Dose (SAD)

PLACEBO COMPARATOR

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

Drug: BMS-986195Other: Placebo

Multiple Ascending Dose(MAD)

PLACEBO COMPARATOR

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

Drug: BMS-986195Other: Placebo

Japanese-Multiple Ascending Dose(MAD)

PLACEBO COMPARATOR

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

Drug: BMS-986195Other: Placebo

Relative Bioavailability with Food Effects (Open Label)

EXPERIMENTAL
Drug: BMS-986195

Interventions

BMS-986195DRUG

Specified dose on specified day

Japanese-Multiple Ascending Dose(MAD)Multiple Ascending Dose(MAD)Relative Bioavailability with Food Effects (Open Label)Single Ascending Dose (SAD)
PlaceboOTHER

Specified dose on specified day

Japanese-Multiple Ascending Dose(MAD)Multiple Ascending Dose(MAD)Single Ascending Dose (SAD)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Melbourne, Victoria, 3004, Australia

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

branebrutinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 11, 2016

Study Start

August 18, 2016

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

AU(1)