Effect of Diltiazem on Pharmacokinetics of BMS-914392

NCT ID: NCT01211808

Last Updated: 2011-02-02

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose BMS-914392 in healthy subjects.

Detailed Description

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Protocol designed to evaluate the potential for a drug-drug interaction

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment A (BMS-914832)

Group Type EXPERIMENTAL

BMS-914832

Intervention Type DRUG

Tablets, Oral, 30 mg, once, 1 day

Treatment B (BMS-914832 + diltiazem)

Group Type EXPERIMENTAL

BMS-914832

Intervention Type DRUG

Tablets, Oral, 30 mg, once, 1 day

Diltiazem

Intervention Type DRUG

Tablets, Oral, 360 mg, once daily, 10 days

Interventions

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BMS-914832

Tablets, Oral, 30 mg, once, 1 day

Intervention Type DRUG

Diltiazem

Tablets, Oral, 360 mg, once daily, 10 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy

Exclusion Criteria

* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Current or history of neurological diseases or psychiatric disorders and cardiovascular diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PRA Health Sciences

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Pra International

Lenexa, Kansas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV203-002

Identifier Type: -

Identifier Source: org_study_id

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