NCT00839891

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

A Phase 1 Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group/Crossover Thorough QT/QTc Study to Evaluate the Effect of a Therapeutic Dose and a Supra-therapeutic Dose of VI-0521 on Cardiac Repolarization in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This three-arm, parallel group, double-blind, active- and placebo-controlled study comparing VI-0521 at a potential therapeutic dose of PHEN/TPM 7.5/46 and PHEN/TPM 22.5/138 , a supra-therapeutic dose, with placebo. A single oral dose of 400 mg moxifloxacin is included as a positive control in terms of the effect on cardiac repolarization. The three treatment regimens are defined as follows: 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; A total of 112 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be randomized.Subjects will check into the clinical research unit (CRU) on Day -1. Day 1 will be a baseline electrocardiogram (ECG) profile day (all groups). Active dosing for Group 1 with VI-0521 will commence on Day 2. VI-0521 dose will escalate every 2-3 days until steady-state is achieved on Day 10 for the therapeutic dose PHEN/TPM 7.5/46. A full ECG assessment day will be performed (all groups, blinded); enabling the comparison of VI 0521 PHEN/TPM 7.5/46 with the placebo (pooled Groups 2 and 3).Subsequently, VI-0521 doses will be escalated until subjects in Group 1 reach a dose of 22.5/138, and then continue at this dose level until Day 22. On Day 22, when the active group has reached a steady state for the supratherapeutic dose level, another ECG assessment day will be performed (all groups, blinded); enabling a comparison of supratherapeutic VI-0521 with placebo (pooled Groups 2 and 3). Groups 2 and 3 will receive VI-0521 placebo on Days 2 to 22.

Conditions

• Torsades de Pointes

Interventions

Type	Name	Description
DRUG	VI-0521	PHEN/TPM 7.5/46 mg (a potential therapeutic dose) PHEN/TPM 22.5/138 mg (a supra-therapeutic dose)

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-02-10
• Last updated: 2010-01-21

Locations

1 site across 1 country: United States