Erectile Dysfunction Clinical Trial
Official title:
A Phase I, Single-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Arm Study of the Effects of Avanafil on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects
This study is designed to look into the effect of avanafil on blood levels of warfarin and to investigate its effect on prothrombin time/international normalized ratio (INR) in healthy men.
The trial is a single-centre, double-blind, randomized, placebo-controlled, 2-way crossover
drug interaction study with at least a 21-day washout period.
Each subject will participate in two sessions in which they will be randomized to receive
either 200 mg of avanafil or matching placebo for 9 days. On Day 3 of each period, subjects
will receive a single dose of warfarin (25 mg). Following the warfarin dose, pharmacokinetic
and pharmacodynamic sampling will be taken over a period of 7 days. Subjects will be
discharged on Day 10 following the end-of-period evaluation. There will be a washout of at
least 21 days between the warfarin doses. The study medications will be administered with
240 mL of water following an overnight fast of at least 10 hours.
Blood samples (3 mL) for the assessment of R- and S-warfarin concentrations in plasma will
be drawn on Day 3 prior to warfarin administration and 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 48,
72, 96, 120, 144, and 168 hours after the warfarin administration.
Blood samples (3 mL) for the assessment of avanafil and/or metabolite concentrations will be
drawn on Day 3 prior to avanafil (or placebo) administration and at 0.5, 1, and 2 hours
post-dose.
Blood samples (4.5 mL) for the assessment of prothrombin time (PT) and international
normalized ratio (INR) will be drawn at screening, check-in, on Day 3 prior to warfarin
administration and at 6, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose.
Blood samples (4.5 mL) for collagen-induced platelet aggregation will be drawn on Day 3
prior to warfarin administration and at 1, 4, 6, 12, and 24 hours post-dose.
A blood sample (8.5 mL) for VKORC1 and CYP2C9 genotyping will be drawn at the check-in for
Period 1.
The overall blood volume required for this study (assuming direct venipuncture for each
sample) will be approximately 446 mL.
All subjects will be confined at the Clinical Research Unit starting in on Day -2 for diet
equilibration and will remain confined for approximately 24 hours following the last study
drug administration on Day 9.
Adverse events, laboratory evaluations, electrocardiogram, physical examination, and vital
signs will be assessed at various times during the study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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