Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Atrial Fibrillation Clinical Trial

Official title:

Effect of BMS-914392 on the Pharmacokinetics of Metoprolol and on Heart Rate After Co-administration of BMS-914392 and Metoprolol in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211821
• Other study ID #: CV203-003
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2010
• Last updated: February 1, 2011
• Start date: September 2010
• Est. completion date: November 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 the study is to assess the effects of BMS-914392 administration on the pharmacokinetics of a single-dose of metoprolol in healthy subjects.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2010
• Est. primary completion date: November 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.

• Subjects genotyped as Intermediate, Extensive or Ultra-rapid CYP2D6 metabolizers

• Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy

Exclusion Criteria:

• Any significant acute or chronic medical illness.

• Current or recent (within 3 months of study drug administration) gastrointestinal disease.

• Current or history of neurological diseases or psychiatric disorders, cardiovascular diseases, and bronchospastic diseases.

• CYP2D6 poor metabolizers based on genotype

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• metoprolol
Tablets, Oral, 200 mg, once, 1 day
• BMS-914392
Tablets, Oral, 60 mg, once daily, 7 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 metoprolol derived from serial measurements of metoprolol plasma concentrations		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, and 36 Hr after dosing of metoprolol alone or in combination with BMS-914392	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 with metoprolol alone or in combination with BMS-914392	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