Back to resultsEvaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants
Primary Purpose
Thrombosis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BMS-986177
BMS-986177
Sponsored by
About this trial
This is an interventional other trial for Thrombosis
Eligibility Criteria
Inclusion Criteria:
- Body mass index 18.0 to 32.0 kg/m2, inclusive
- Women must not be of childbearing potential (cannot become pregnant)
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Head injury in the last 2 years
- History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.
Other protocol defined inclusion / exclusion criteria could apply
Sites / Locations
- Quotient Clinical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Receive 200 mg BMS-986177 Form A without food
Receive 200 mg BMS-986177 Form B without food
Receive 200 mg BMS-986177 Form B with food
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Measured by plasma concentration
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
Measured by plasma concentration
AUC from time zero extrapolated to infinite time (AUC(INF))
Measured by plasma concentration
Secondary Outcome Measures
Incidence of Adverse Events (AEs)
Safety and tolerability as measured by incidence of AEs
Incidence of Serious Adverse Events (SAEs)
Safety and tolerability as measured by incidence of SAEs
Number of participants with electrocardiogram abnormalities
Number of participants with physical examination abnormalities
Number of participants with clinical laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03362437
Brief Title
Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants
Official Title
A Study to Evaluate the Pharmacokinetics of BMS-986177 From Form A and Form B in Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
December 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Receive 200 mg BMS-986177 Form A without food
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Receive 200 mg BMS-986177 Form B without food
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
Receive 200 mg BMS-986177 Form B with food
Intervention Type
Drug
Intervention Name(s)
BMS-986177
Intervention Description
Form A
Intervention Type
Drug
Intervention Name(s)
BMS-986177
Intervention Description
Form B
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Description
Measured by plasma concentration
Time Frame
Up to 3 days
Title
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
Description
Measured by plasma concentration
Time Frame
Up to 3 days
Title
AUC from time zero extrapolated to infinite time (AUC(INF))
Description
Measured by plasma concentration
Time Frame
Up to 3 days
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Description
Safety and tolerability as measured by incidence of AEs
Time Frame
Up to 12 days
Title
Incidence of Serious Adverse Events (SAEs)
Description
Safety and tolerability as measured by incidence of SAEs
Time Frame
Up to 30 days
Title
Number of participants with electrocardiogram abnormalities
Time Frame
Up to 12 days
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 12 days
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 12 days
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
Inclusion Criteria:
Body mass index 18.0 to 32.0 kg/m2, inclusive
Women must not be of childbearing potential (cannot become pregnant)
Exclusion Criteria:
Any significant acute or chronic medical illness
Head injury in the last 2 years
History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.
Other protocol defined inclusion / exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Briston-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Quotient Clinical
City
Ruddington
State/Province
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/Recalls
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants
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