Effect of Diltiazem on Pharmacokinetics of BMS-914392

Bristol-Myers Squibb24 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

BMS-914832DRUG

Tablets, Oral, 30 mg, once, 1 day

DiltiazemDRUG

Tablets, Oral, 360 mg, once daily, 10 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Pra International

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations

Time frame: 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

Secondary Outcomes

The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)

Time frame: 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

Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392

Time frame: Daily

Data from ClinicalTrials.gov

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