NCT01054430

Brief Summary

The objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

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

Erectile Dysfunction

Keywords

AvanafilHepaticErectile DysfunctionImpairment

Outcome Measures

Primary Outcomes (1)

  • Single Dose Pharmacokinetics of avanafil

    1 day

Secondary Outcomes (1)

  • single dose safety

    1 day

Study Arms (3)

Normal

OTHER

Subjects with normal hepatic function

Drug: avanafil

Mild Hepatic Dysfunction

OTHER

Subjects with mild hepatic impairment

Drug: avanafil

Moderate hepatic dysfunction

OTHER

Subjects with moderal hepatice impairment

Drug: avanafil

Interventions

avanafilDRUG

200 mg avanafil tablets QD

Mild Hepatic DysfunctionModerate hepatic dysfunctionNormal

Eligibility Criteria

Age21 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects must be 21-75 years of age; inclusive. Healthy control subjects (Cohort 1) must be medically healthy with clinically insignificant screening results and hepatically impaired subjects (Cohorts 2 and 3) must have mild or moderate hepatic impairment based on the Child-Pugh Classification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Shiyin Yee, PhD

    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