Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents (NCT02201342) | Clinical Trial Compass
CompletedPhase 1/2
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
United States36 participantsStarted 2014-07
Plain-language summary
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.
Who can participate
Age range14 Years – 18 Years
SexALL
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Inclusion criteria
✓. Males and females with Fontan physiology who are 14-18 years of age.
✓. Willingness to return to center to complete blood draws and exercise tests as described in the study protocol.
✓. Patients must agree to abstain from alcohol, caffeinated beverages, and grapefruit juice for the duration of the trial.
✓. Informed assent from subject informed consent from parent/legal guardian as appropriate.
Exclusion criteria
✕. Non-cardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
✕. Height \<132 cm (minimum height requirement for exercise stress testing).
✕. Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \>4 mmHg between the regions proximal and distal to the obstruction.
✕. Single lung physiology.
✕. Severe ventricular dysfunction or valvular regurgitation (systemic atrioventricular or semilunar valve) determined from review of the echocardiogram performed in closest proximity to study enrollment.
✕. Significant renal (serum creatinine \> 2.0), hepatic (serum aspartate aminotransferase (AST) and/or alanine aminotransferase ( ALT) \> 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications, based on laboratory assessment at the time of screening visit.
What they're measuring
1
Number of Subjects With Serious Adverse Events Possibly or Probably Related to Udenafil