To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-02-28

Brief Summary

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The objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.

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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal

Subjects with normal hepatic function

Group Type OTHER

avanafil

Intervention Type DRUG

200 mg avanafil tablets QD

Mild Hepatic Dysfunction

Subjects with mild hepatic impairment

Group Type OTHER

avanafil

Intervention Type DRUG

200 mg avanafil tablets QD

Moderate hepatic dysfunction

Subjects with moderal hepatice impairment

Group Type OTHER

avanafil

Intervention Type DRUG

200 mg avanafil tablets QD

Interventions

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avanafil

200 mg avanafil tablets QD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects must be 21-75 years of age; inclusive. Healthy control subjects (Cohort 1) must be medically healthy with clinically insignificant screening results and hepatically impaired subjects (Cohorts 2 and 3) must have mild or moderate hepatic impairment based on the Child-Pugh Classification.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes