A Phase 1 interventional study of 200 mg Avanafil and Placebo in Erectile Dysfunction, sponsored by VIVUS LLC. Completed. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-07.
Sponsored by VIVUS LLC · Phase 1, Interventional, and Treatment
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.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's enrollment of 24 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →VIVUS LLC is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Drug: 200 mg Avanafil
Drug: Placebo
2 X 100mg tablets avanafil
2 tablets
Pharmacokinetics - PK parameters AUC, C-max and t-max of R-and S-warfarin
Time frame: 24 hrs
Pharmacodynamics - Prothrombin time, INR values, and area under effect-time curve (AUEC) of prothrombin and INR on days 14 and 15
Time frame: 24 hours
No study locations are listed for this record.
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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VIVUS LLC