Effect of Diltiazem on Pharmacokinetics of BMS-914392
- Registration Number
- NCT01211808
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose BMS-914392 in healthy subjects.
- Detailed Description
Protocol designed to evaluate the potential for a drug-drug interaction
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment B (BMS-914832 + diltiazem) Diltiazem - Treatment A (BMS-914832) BMS-914832 - Treatment B (BMS-914832 + diltiazem) BMS-914832 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392 Daily
Trial Locations
- Locations (1)
Pra International
🇺🇸Lenexa, Kansas, United States