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

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: VIVUS, Inc.

Trial Summary

What is the purpose of this trial?

* 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.

Eligibility Criteria

Inclusion Criteria

Males or females, aged 19 to 50 years, inclusive.

Body mass index (BMI) between 24 and 30 kg/m2, inclusive.

Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.

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Treatment Details

Interventions

VI-0521 (Other)

Participant Groups

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;