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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02705989




Registration number
NCT02705989
Ethics application status
Date submitted
7/03/2016
Date registered
11/03/2016
Date last updated
30/01/2019

Titles & IDs
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
Secondary ID [1] 0 0
IM014-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986195
Other interventions - Placebo

Placebo Comparator: Single Ascending Dose (SAD) - Single ascending dose of BMS-986195 or Placebo matching BMS-986195

Placebo Comparator: Multiple Ascending Dose(MAD) - Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195

Placebo Comparator: Japanese-Multiple Ascending Dose(MAD) - Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage

Experimental: Relative Bioavailability with Food Effects (Open Label) -


Treatment: Drugs: BMS-986195
Specified dose on specified day

Other interventions: Placebo
Specified dose on specified day
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 8 days during and after last dose
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 21 days during and after last dose

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2017
Sample size
Target
Accrual to date
Final
439
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02705989
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02705989