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.
This single-center, open-label, non-randomized, two-cohort, single-dose pharmacokinetic study will be conducted at a single site in the United States, in which at least 18 young (18-45 years, inclusive) male subjects in Cohort A and 14 elderly (65 years or older) males in Cohort B will be enrolled and dosed to achieve a total of at least 14 completed young subjects and 12 elderly subjects. Seminal fluid and plasma will be collected from Cohort A, whereas only plasma samples will be collected from Cohort B.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
single dose tablet of 200mg avanafil
single tablet dose of 200mg avanafil
MDS Pharma Services
Tempe, Arizona, United States
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
Time frame: 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.
Time frame: pre-dose (baseline) through 24 hours post-dose
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