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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Renal Impairment Study for PF-04965842

NCT03660241

Renal Impairment

COMPLETED PHASE1

An Open-label, Parallel-group Study to Determine the Pharmacokinetics of a Single Dose of AFQ056 in Subjects With Renal Impairment Compared to Healthy Subjects

NCT01442259

Mild Moderate or Severe Renal Impairment

COMPLETED PHASE1

Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function

NCT02508506

Renal Impairment

COMPLETED PHASE1

Pharmacokinetics in Subjects With Renal Impairment

NCT01504165

Renal Impairment

COMPLETED PHASE1

PF-04634817 Renal Impairment Study

NCT01791855

Renal Insufficiency

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal

Normal renal function

Group Type OTHER

avanafil

Intervention Type DRUG

200 mg avanafil tablet QD

Mild

Mild renal impairment

Group Type OTHER

avanafil

Intervention Type DRUG

200 mg avanafil tablet QD

Moderate

Moderate renal impairment

Group Type OTHER

avanafil

Intervention Type DRUG

200 mg avanafil tablet QD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

avanafil

200 mg avanafil tablet QD

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

78 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes