|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | VIVUS, Inc. |
|---|---|
| Information provided by: | VIVUS, Inc. |
| ClinicalTrials.gov Identifier: | NCT00839891 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Torsades de Pointes |
Drug: VI-0521 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
| Official Title: | 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 |
| Enrollment: | 112 |
| Study Start Date: | February 2009 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
3: Placebo Comparator
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; |
Drug: VI-0521
PHEN/TPM 7.5/46 mg (a potential therapeutic dose) PHEN/TPM 22.5/138 mg (a supra-therapeutic dose)
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Vivus, inc. ( Wesley Day, VP Clinical ) |
| Study ID Numbers: | OB-118 |
| Study First Received: | February 6, 2009 |
| Last Updated: | January 20, 2010 |
| ClinicalTrials.gov Identifier: | NCT00839891 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
TQT, QTc |
|
Pathologic Processes Heart Diseases Tachycardia Torsades de Pointes |
Cardiovascular Diseases Tachycardia, Ventricular Arrhythmias, Cardiac |