Effect of Diltiazem on Pharmacokinetics of BMS-914392

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Atrial Fibrillation

Treatments: Drug: BMS-914832; Drug: Diltiazem

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211808

CV203-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 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
• 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

Trial design

24 participants in 2 patient groups

Treatment A (BMS-914832)

Experimental group

Treatment:

Drug: BMS-914832

Treatment B (BMS-914832 + diltiazem)

Experimental group

Treatment:

Drug: BMS-914832

Drug: Diltiazem