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A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

NCT00914511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-01-07

No results posted yet for this study

Summary

The purposes of this study are to:

* Determine the effect of the study drug on sperm and semen of healthy young male subjects.
* Determine the effect of age on the amount of study drug in the blood of healthy subjects
* Learn about the safety of the study drug.
* Learn how subjects tolerate the study drug.

Conditions

  • Avanfil ADME
  • Semen Exposure
  • Sperm Function

Interventions

DRUG

avanafil 200mg

single dose tablet of 200mg avanafil

DRUG

avanafil 200mg

single tablet dose of 200mg avanafil

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Shiyin Yee, PhD · VIVUS LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00914511 on ClinicalTrials.gov