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VI-0521 for Torsades de Pointes (TQT Trial)

Phase 1
Waitlist Available
Research Sponsored by VIVUS, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Placebo Group
Group I: 3Placebo Group1 Intervention
Group 1: 56 subjects to receive active study drug (VI-0521) at steady state, PHEN/TPM 7.5/46 (a potential therapeutic dose), escalating to PHEN/TPM 22.5/138 (a supra-therapeutic dose); Group 2: 28 subjects to receive placebo preceded by a single oral dose of moxifloxacin on Day 2; Group 3: 28 subjects to receive placebo followed by a single oral dose of moxifloxacin on Day 24;

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

VIVUS, Inc.Lead Sponsor
39 Previous Clinical Trials
9,855 Total Patients Enrolled
VIVUS LLCLead Sponsor
43 Previous Clinical Trials
10,502 Total Patients Enrolled
Shiyin Yee, PhDStudy DirectorClinical Pharmacology Consultant
8 Previous Clinical Trials
240 Total Patients Enrolled
~7 spots leftby Oct 2025
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