NCT01054261

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 7, 2011

Status Verified

January 1, 2011

Enrollment Period

1 month

First QC Date

January 20, 2010

Last Update Submit

January 5, 2011

Conditions

Renal

Keywords

avanafil, renal, impairment, TA-1790

Outcome Measures

Primary Outcomes (1)

  • Single dose PK of avanafil

    1 day

Study Arms (3)

Normal

OTHER

Normal renal function

Drug: avanafil

Mild

OTHER

Mild renal impairment

Drug: avanafil

Moderate

OTHER

Moderate renal impairment

Drug: avanafil

Interventions

avanafilDRUG

200 mg avanafil tablet QD

MildModerateNormal

Eligibility Criteria

Age21 Years - 78 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male subjects,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

avanafil

Study Officials

  • Shiyin Yee

    VIVUS LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 22, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 7, 2011

Record last verified: 2011-01