Status:

COMPLETED

Effect of Diltiazem on Pharmacokinetics of BMS-914392

Lead Sponsor:

Bristol-Myers Squibb

Collaborating Sponsors:

PRA Health Sciences

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

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

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

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

September 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2010

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT01211808

Start Date

September 1 2010

End Date

October 1 2010

Last Update

February 2 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Pra International

Lenexa, Kansas, United States, 66219