Trials / Completed
CompletedNCT01054430
To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.
A PHASE I, OPEN LABEL, NON-RANDOMIZED, SINGLE-DOSE, PARALLEL-COHORT, MATCHED-CONTROL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF AVANAFIL (TA-1790) IN SUBJECTS WITH HEPATIC IMPAIRMENT AND IN HEALTHY CONTROL MALE SUBJECTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- VIVUS LLC · Industry
- Sex
- Male
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | avanafil | 200 mg avanafil tablets 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
Source: ClinicalTrials.gov record NCT01054430. Inclusion in this directory is not an endorsement.