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

NCT ID: NCT02922452

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BMS-986141 and Dilitazem

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Single dose BMS-986141 and Multiple doses of Dilitazem

Dilitazem

Intervention Type DRUG

Single dose BMS-986141 and Multiple doses of Dilitazem

Interventions

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BMS-986141

Single dose BMS-986141 and Multiple doses of Dilitazem

Intervention Type DRUG

Dilitazem

Single dose BMS-986141 and Multiple doses of Dilitazem

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PPD Development

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/studyconnect/pages/home.aspx

BMS Clinical Trial Education Resource

http://www.fda.gov/Safety/Recalls/

FDA Safety Alerts and Recalls

http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

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CV006-028

Identifier Type: -

Identifier Source: org_study_id