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A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers

NCT00839891 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2010-01-21

No results posted yet for this study

Summary

* Determine whether VI-0521 has an effect on the electrical activity of the heart in healthy subjects.
* Find out how much VI-0521 is in the blood and any potential side effects on ECG's of healthy subjects after taking the study drugs.

Conditions

  • Torsades de Pointes

Interventions

DRUG

VI-0521

PHEN/TPM 7.5/46 mg (a potential therapeutic dose) PHEN/TPM 22.5/138 mg (a supra-therapeutic dose)

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Shiyin Yee, PhD · Clinical Pharmacology Consultant

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00839891 on ClinicalTrials.gov