Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BMS-986195
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Placebo Comparator
Experimental
Arm Label
Single Ascending Dose (SAD)
Multiple Ascending Dose(MAD)
Japanese-Multiple Ascending Dose(MAD)
Relative Bioavailability with Food Effects (Open Label)
Arm Description
Single ascending dose of BMS-986195 or Placebo matching BMS-986195
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02705989
Brief Title
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 18, 2016 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
439 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Ascending Dose (SAD)
Arm Type
Placebo Comparator
Arm Description
Single ascending dose of BMS-986195 or Placebo matching BMS-986195
Arm Title
Multiple Ascending Dose(MAD)
Arm Type
Placebo Comparator
Arm Description
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195
Arm Title
Japanese-Multiple Ascending Dose(MAD)
Arm Type
Placebo Comparator
Arm Description
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
Arm Title
Relative Bioavailability with Food Effects (Open Label)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986195
Intervention Description
Specified dose on specified day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified day
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
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Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
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