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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01054261

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

Renal

Keywords

avanafil, renal, impairment, TA-1790

Brief 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.

Interventions

DRUGavanafil

200 mg avanafil tablet QD

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to 78 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult male subjects, * 21-78 years of age, must be medically healthy with no clinically significant screening results (except for the subjects in Groups 2 and 3). * Subjects with normal renal function (Group 1) must have an estimated CLcr of ≥80 mL/min. * Subjects with renal impairment (Groups 2 and 3) must fulfill the additional following criteria: (a) Stable renal impairment; (b) Group 2 subjects with mild renal impairment must have a CLcr of ≥50 to \<80 mL/min and (c) Group 3 subjects with moderate renal impairment must have a CLcr of ≥30 to \<50 mL/min.

Exclusion criteria

* Major

Design outcomes

Primary

Measure	Time frame
Single dose PK of avanafil	1 day

Outcome results

None listed

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