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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01054430

Acronym

avanafil

Enrollment

Registered

2010-01-22

Start date

2010-01-31

Completion date

2010-02-28

Last updated

2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Avanafil, Hepatic, Erectile Dysfunction, Impairment

Brief 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.

Interventions

DRUGavanafil

200 mg avanafil tablets QD

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to 75 Years

Healthy volunteers

Yes

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.

Exclusion criteria

* Main

Design outcomes

Primary

Measure	Time frame
Single Dose Pharmacokinetics of avanafil	1 day

Secondary

Measure	Time frame
single dose safety	1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026