CClinicalTrials.gg
CompletedNCT01054261Updated Jan 7, 2011

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

A Phase 1 interventional study of avanafil in Renal, sponsored by VIVUS LLC. Completed. Open to male participants aged 21 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-07.

Sponsored by VIVUS LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
21 Years to 78 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Renal

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Keywords

  • avanafil, renal, impairment, TA-1790
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 24 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

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Lead sponsor

VIVUS LLC is the lead sponsor of 40 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 78 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    Normal

    Normal renal function

    Drug: avanafil

  • Other
    Mild

    Mild renal impairment

    Drug: avanafil

  • Other
    Moderate

    Moderate renal impairment

    Drug: avanafil

Interventions

  • Drugavanafil

    200 mg avanafil tablet QD

06

What researchers measure

Primary outcomes

  1. Single dose PK of avanafil

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01054261
Lead sponsor
VIVUS LLC
First posted
Jan 22, 2010
Start date
Jan 2010
Primary completion
Feb 2010
Completion
Feb 2010
Last update
Jan 7, 2011

Study contacts

Shiyin Yee
study director · VIVUS LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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