A Phase I, Single-Center, Open-Label, Non-Randomized, Two-Cohort Study to Assess the Effect of Age on the Pharmacokinetics of Avanafil And To Determine Avanafil Semen Exposure and the Acute Effect of Avanafil on Sperm Function in Healthy Young Male Subjects Following a Single Oral Dose of 200 mg
Sponsor study identifier
interventional
32
1 country
1
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)The purposes of this study are to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 2009
Actual (reported)June 2009
Actual (reported)June 3, 2009
Actual (reported)June 5, 2009
Actual (reported)Plasma pharmacokinetic parameters of avanafil and its metabolites will be evaluated including AUC (0-t), AUC(0-inf), Cmax, fu, t1/2, and tmax; Sperm motility, function and morphology; Avanafil exposure in seminal fluid
pre-dose (baseline) through 24 hours post-dose
adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study.
pre-dose (baseline) through 24 hours post-dose
Healthy young males age 18-45, inclusive
Elderly males 65 years of age and older
single dose tablet of 200mg avanafil
single tablet dose of 200mg avanafil
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MDS Pharma Services
Tempe, Arizona, 85283, United States
Shiyin Yee, PhD
VIVUS LLC
32 participants (actual enrollment reported by the registry).
First Submitted
June 3, 2009
First Posted
June 5, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
January 7, 2011
Record last verified: 2011-01
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Source: ClinicalTrials.gov.
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