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

This study has been completed.
Sponsor:
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01054261
First received: January 20, 2010
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Renal
Drug: avanafil
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Single dose PK of avanafil [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Normal
Normal renal function
Drug: avanafil
200 mg avanafil tablet QD
Mild
Mild renal impairment
Drug: avanafil
200 mg avanafil tablet QD
Moderate
Moderate renal impairment
Drug: avanafil
200 mg avanafil tablet QD

  Eligibility

Ages Eligible for Study:   21 Years to 78 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054261

Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Shiyin Yee VIVUS, Inc.
  More Information

No publications provided

Responsible Party: Wesley Day, VP Clinical Operations
ClinicalTrials.gov Identifier: NCT01054261     History of Changes
Other Study ID Numbers: TA-013
Study First Received: January 20, 2010
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
avanafil, renal, impairment, TA-1790

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014