A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects

Phase 1

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: BMS-986141; Drug: Dilitazem

• Registration Number: NCT02922452
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Signed Informed Consent
2. 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.
3. Subjects with body mass index of 18 to 32 kg/m2, inclusive.
4. Women participants must have documented proof that they are not of childbearing potential.
5. 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

1. Acute or chronic medical illness, subjects with bleeding diathesis, gastrointestinal ulcer, hepatic disease.
2. 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.
3. 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.
4. History of allergy to BMS-986141, dilitazem or any other significant drug allergy or adverse reaction to anticoagulants or antiplatelets.
5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986141 and Dilitazem	Dilitazem	-
BMS-986141 and Dilitazem	BMS-986141	-

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Days 1-21
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Days 1-21
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T))	Days 1-21

Secondary Outcome Measures

Name	Time	Method
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death	Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last]

Trial Locations

Locations (1)

PPD Development; 🇺🇸 Austin, Texas, United States