Effect of Diltiazem on Pharmacokinetics of BMS-914392

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211808
• Other study ID #: CV203-002
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2010
• Last updated: February 1, 2011
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• BMS-914832
Tablets, Oral, 30 mg, once, 1 day
• Diltiazem
Tablets, Oral, 360 mg, once daily, 10 days

Locations

Country	Name	City	State
United States	Pra International	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations		Pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, and 96 hours after dosing of BMS-914392 alone or in combination with diltiazem	No
Secondary	The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)		Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing of BMS-914392 alone or in combination with diltiazem	No
Secondary	Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392		Daily	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form