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

NCT02922452 | Completed Phase 1

• 1 other identifier: CV006-028
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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]

Study Arms (1)

BMS-986141 and Dilitazem

EXPERIMENTAL

Drug: BMS-986141; Drug: Dilitazem

Interventions

BMS-986141 DRUG

Single dose BMS-986141 and Multiple doses of Dilitazem

BMS-986141 and Dilitazem

Dilitazem DRUG

Single dose BMS-986141 and Multiple doses of Dilitazem

BMS-986141 and Dilitazem

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Development

Austin, Texas, 78744, United States

Location

Related Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Conditions

Ischemic Stroke

Interventions

BMS-986141

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 4, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

US (1)