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