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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 atrial-fibrillation
Started Sep 2010
Shorter than P25 for phase_1 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFebruary 2, 2011
February 1, 2011
1 month
September 3, 2010
February 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Treatment A (BMS-914832)
EXPERIMENTALTreatment B (BMS-914832 + diltiazem)
EXPERIMENTALInterventions
Tablets, Oral, 30 mg, once, 1 day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Current or history of neurological diseases or psychiatric disorders and cardiovascular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- PRA Health Sciencescollaborator
Study Sites (1)
Pra International
Lenexa, Kansas, 66219, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 30, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 2, 2011
Record last verified: 2011-02