Effect of BMS-914392 on Pharmacokinetics of Metoprolol

NCT01211821 | Completed Phase 1

• 1 other identifier: CV203-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations

  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, and 36 Hr after dosing of metoprolol alone or in combination with BMS-914392

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 with metoprolol alone or in combination with BMS-914392

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

  Daily

Study Arms (2)

metoprolol

OTHER

Treatment A

Drug: metoprolol

BMS-914392 + metoprolol

EXPERIMENTAL

Treatment B

Drug: metoprolol; Drug: BMS-914392

Interventions

metoprolol DRUG

Tablets, Oral, 200 mg, once, 1 day

BMS-914392 + metoprolol; metoprolol

BMS-914392 DRUG

Tablets, Oral, 60 mg, once daily, 7 days

BMS-914392 + metoprolol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• Subjects genotyped as Intermediate, Extensive or Ultra-rapid CYP2D6 metabolizers
• Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy

You may not qualify if:

• Any significant acute or chronic medical illness.
• Current or recent (within 3 months of study drug administration) gastrointestinal disease.
• Current or history of neurological diseases or psychiatric disorders, cardiovascular diseases, and bronchospastic diseases.
• CYP2D6 poor metabolizers based on genotype

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• PRA Health Sciences: collaborator

Study Sites (1)

Pra International

Lenexa, Kansas, 66219, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

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: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 2, 2011

Record last verified: 2011-02

Locations

US (1)