Effect of Diltiazem on Pharmacokinetics of BMS-914392

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211808

Enrollment

Registered

2010-09-30

Start date

2010-09-30

Completion date

2010-10-31

Last updated

2011-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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

Interventions

DRUGBMS-914832

Tablets, Oral, 30 mg, once, 1 day

DRUGDiltiazem

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026