NCT01054261

To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.

A Phase I, Open-Label, Parallel-Group, Single Dose, Non-Randomized Study to Compare the Pharmacokinetics of Avanafil in Male Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Male
• Age: 21 Years – 78 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment and to assess the safety and toleration of avanafil in subjects with mild and moderate renal impairment.

Conditions

• Renal

Interventions

Type	Name	Description
DRUG	avanafil	200 mg avanafil tablet QD

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-01-22
• Last updated: 2011-01-07