NCT01415128

Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects

A PHASE I, SINGLE-CENTER, OPEN-LABEL, CROSSOVER STUDY OF THE EFFECT OF AVANAFIL ON THE PHARMACOKINETICS OF OMEPRAZOLE, DESIPRAMINE AND ROSIGLITAZONE IN HEALTHY MALE SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will compare the pharmacokinetics of omeprazole, rosiglitazone and desipramine when administered with a single oral dose of avanafil in healthy male subjects.

Detailed description

There will be three cohorts in this Phase I, single-center, open-label, crossover study: Cohort A (omeprazole): This is a open-label, non-randomized, one-sequence crossover study design, in which 20 healthy male subjects will be enrolled and administered a single oral dose of 40 mg omeprazole once daily for 8 days (Days 1-8) plus a single oral dose of 200 mg avanafil on Day 8. On Days 7 and 8, avanafil and/or omeprazole doses will be administered following an overnight fast of at least 10 hours. All subjects will be confined at the Clinical Research Unit the day prior to the omeprazole administration on Day 7 and will remain confined for approximately 13 hours following the dosing on Day 8. Blood samples for determination of plasma omeprazole concentrations will be obtained from all subjects at 0 (10 minutes pre-dose), 20, 40 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 7 and 8. Pre-dose blood samples for determination of omeprazole will also be taken in the morning on Days 5-6. Cohort B (rosiglitazone): This is a randomized, open-label, two-period crossover study design, in which 20 male subjects will be randomized to receive the following treatments: * Treatment A: a single oral dose of 8 mg rosiglitazone following an overnight fast of at least 10 hours. * Treatment B: a single oral dose of 8 mg rosiglitazone plus a single oral dose of 200 mg avanafil following an overnight fast of at least 10 hours. The two treatments in the cohort will be separated by a washout period of at least 7 days. All subjects will be confined at the Clinical Research Unit approximately from the morning of Day -1 to the morning of Day 2 in both treatment periods. Blood samples for determination of plasma rosiglitazone concentrations will be obtained from all subjects at 0 (10 minutes pre-dose) and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 16 and 24 hours post-dose. Cohort C (desipramine): This is a randomized, open-label, two-period, crossover study design, in which 20subjects identified as CYP2D6 extensive metabolizers (determined by genotyping) will be randomized to receive the following treatments: * Treatment A: a single oral dose of 50 mg desipramine following an overnight fast of at least 10 hours. * Treatment B: a single oral dose of 50 mg desipramine plus a single oral dose of 200 mg avanafil following an overnight fast of at least 10 hours. The avanafil dose will be administered 2 hours after the desipramine administration. The two treatments in the cohort will be separated by a washout period of at least 10 days. All subjects will be confined at the Clinical Research Unit from the morning of Day -1 to the morning of Day 2 in both treatment periods. Blood samples for determination of plasma desipramine concentrations will be obtained from all subjects at 0 (10 minutes pre-dose) and 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post-dose. Subjects will visit the study site as outpatients in the morning for their remaining PK blood sample collection on Days 3-5.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Omeprazole	Once a day dosing of Omeprazole (40 mg) for 8 days
DRUG	Rosiglitazone	Single dose of Rosiglitazone (8 mg) for 1 day
DRUG	Desipramine	Single dose of Desipramine (50 mg) for 1 day

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2011-08-11
• Last updated: 2011-08-11