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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:
ClinicalTrials.gov Identifier:
NCT01054261
First Posted: January 22, 2010
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VIVUS, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 78 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054261


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

Responsible Party: Wesley Day, VP Clinical Operations
ClinicalTrials.gov Identifier: NCT01054261     History of Changes
Other Study ID Numbers: TA-013
First Submitted: January 20, 2010
First Posted: January 22, 2010
Last Update Posted: January 7, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases