NCT00914511

A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

A Phase I, Single-Center, Open-Label, Non-Randomized, Two-Cohort Study to Assess the Effect of Age on the Pharmacokinetics of Avanafil And To Determine Avanafil Semen Exposure and the Acute Effect of Avanafil on Sperm Function in Healthy Young Male Subjects Following a Single Oral Dose of 200 mg

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purposes of this study are to: * Determine the effect of the study drug on sperm and semen of healthy young male subjects. * Determine the effect of age on the amount of study drug in the blood of healthy subjects * Learn about the safety of the study drug. * Learn how subjects tolerate the study drug.

Detailed description

This single-center, open-label, non-randomized, two-cohort, single-dose pharmacokinetic study will be conducted at a single site in the United States, in which at least 18 young (18-45 years, inclusive) male subjects in Cohort A and 14 elderly (65 years or older) males in Cohort B will be enrolled and dosed to achieve a total of at least 14 completed young subjects and 12 elderly subjects. Seminal fluid and plasma will be collected from Cohort A, whereas only plasma samples will be collected from Cohort B.

Conditions

• Avanfil ADME
• Semen Exposure
• Sperm Function

Interventions

Type	Name	Description
DRUG	avanafil 200mg	single dose tablet of 200mg avanafil
DRUG	avanafil 200mg	single tablet dose of 200mg avanafil

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-06-05
• Last updated: 2011-01-07

Locations

1 site across 1 country: United States