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

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.

Study Overview

• Status: Completed
• Conditions: Renal
• Intervention / Treatment: Drug: avanafil

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal (with the exception of renal insufficiency for subjects in Groups 2 and 3), hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the Investigator; systolic blood pressure < 90 or >160 mmHg; diastolic blood pressure < 50 or > 95 mmHg; allergy to or previous adverse events with PDE5 inhibitors or its constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days prior to Day 1; use of any investigational drug within 30 days prior to Day 1; use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breathe alcohol test; positive cotinine test, positive urine drug screen (except in renally impaired subjects following approval by Sponsor). Additional exclusion criteria are listed in Section 4.2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Normal; Normal renal function	Drug: avanafil; 200 mg avanafil tablet QD
Other: Mild; Mild renal impairment	Drug: avanafil; 200 mg avanafil tablet QD
Other: Moderate; Moderate renal impairment	Drug: avanafil; 200 mg avanafil tablet QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Single dose PK of avanafil	1 day

Collaborators and Investigators

• Sponsor: VIVUS LLC
• Investigators: Study Director: Shiyin Yee, VIVUS LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): January 7, 2011
• Last Update Submitted That Met QC Criteria: January 5, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: avanafil, renal, impairment, TA-1790
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: TA-013