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Effect of Diltiazem on Pharmacokinetics of BMS-914392

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: BMS-914832 (Drug); Diltiazem (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


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

Clinical Details

Official title: Effect of Diltiazem on the Pharmacokinetics of BMS-914392 and on Heart Rate After Single-dose Administration of BMS-914392 in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations

Secondary outcome:

The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)

Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392

Detailed description: Protocol designed to evaluate the potential for a drug-drug interaction


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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


- Current or history of neurological diseases or psychiatric disorders and

cardiovascular diseases

Locations and Contacts

Pra International, Lenexa, Kansas 66219, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: September 2010
Last updated: February 1, 2011

Page last updated: August 23, 2015

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