Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Atrial Fibrillation

Treatments: Drug: BMS-914392; Drug: metoprolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211821

CV203-003

Details and patient eligibility

About

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.

Full description

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 2 patient groups

metoprolol

Other group

Description:

Treatment A

Treatment:

Drug: metoprolol

BMS-914392 + metoprolol

Experimental group

Description:

Treatment B

Treatment:

Drug: metoprolol

Drug: BMS-914392