Back to resultsA Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986141
Dilitazem
Sponsored by
About this trial
This is an interventional basic science trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
- Subjects with body mass index of 18 to 32 kg/m2, inclusive.
- Women participants must have documented proof that they are not of childbearing potential.
- Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986141 plus 5 half-lives plus 90 days for a total of 100 days post-treatment completion.
Exclusion Criteria:
- Acute or chronic medical illness, subjects with bleeding diathesis, gastrointestinal ulcer, hepatic disease.
- History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, important arrhythmias, sinus bradycardia, chronic headaches, history of multiple events of dizziness, periodontal disease and recent blood donation.
- Prior exposure to BMS-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by BMS clinical monitor.
- History of allergy to BMS-986141, dilitazem or any other significant drug allergy or adverse reaction to anticoagulants or antiplatelets.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
Sites / Locations
- PPD Development
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMS-986141 and Dilitazem
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed concentration (Cmax)
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T))
Secondary Outcome Measures
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death
Full Information
NCT ID
NCT02922452
First Posted
September 30, 2016
Last Updated
December 19, 2016
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02922452
Brief Title
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
Official Title
An Open-Label, Single-Sequence Study to Evaluate the Effect of Diltiazem on the Single-Dose Pharmacokinetics of BMS-986141 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (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
This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with parameters like Cmax, AUC(INF), and AUC(0-T).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986141 and Dilitazem
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986141
Intervention Description
Single dose BMS-986141 and Multiple doses of Dilitazem
Intervention Type
Drug
Intervention Name(s)
Dilitazem
Intervention Description
Single dose BMS-986141 and Multiple doses of Dilitazem
Primary Outcome Measure Information:
Title
Maximum observed concentration (Cmax)
Time Frame
Days 1-21
Title
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame
Days 1-21
Title
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T))
Time Frame
Days 1-21
Secondary Outcome Measure Information:
Title
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death
Time Frame
Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent
Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
Subjects with body mass index of 18 to 32 kg/m2, inclusive.
Women participants must have documented proof that they are not of childbearing potential.
Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986141 plus 5 half-lives plus 90 days for a total of 100 days post-treatment completion.
Exclusion Criteria:
Acute or chronic medical illness, subjects with bleeding diathesis, gastrointestinal ulcer, hepatic disease.
History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, important arrhythmias, sinus bradycardia, chronic headaches, history of multiple events of dizziness, periodontal disease and recent blood donation.
Prior exposure to BMS-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by BMS clinical monitor.
History of allergy to BMS-986141, dilitazem or any other significant drug allergy or adverse reaction to anticoagulants or antiplatelets.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
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
PPD Development
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/pages/home.aspx
Description
BMS Clinical Trial Education Resource
URL
http://www.fda.gov/Safety/Recalls/
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
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