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Completed

NCT Number: NCT01211808

Effect of Diltiazem on Pharmacokinetics of BMS-914392

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pra International

Lenexa, Kansas, 66219, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-914832

Drug

Tablets, Oral, 30 mg, once, 1 day

Diltiazem

Drug

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

Primary outcomes

  1. 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

  1. 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

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

    Time frame: Daily

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study title

Effect of Diltiazem on the Pharmacokinetics of BMS-914392 and on Heart Rate After Single-dose Administration of BMS-914392 in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2010
Registry last updated
Feb 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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