Clinical Trial: Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

Brief 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.

Detailed Summary: A dose escalation trial to determine the pharmacokinetics, safety and tolerance of udenafil in male and female adolescent subjects with single ventricle physiology that that have undergone the Fontan surgical procedure. Pharmacodynamic data will also be collected to evaluate the effect of udenafil on acute exercise performance, peripheral vascular function and indices of myocardial performance. Five udenafil cohorts will be evaluated in additional to one drug free cohort
Sponsor: Mezzion Pharma Co. Ltd

Current Primary Outcome: Number of subjects with Serious Adverse Events [ Time Frame: 5 days ]

Safety will be measured by the number of subjects experience serious adverse events possibly or probably related to study drug


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Plasma clearance of parent drug and active metabolite [ Time Frame: Day 5, Zero to 48 hours post last dose ]
    Plasma clearance of parent drug and active metabolite will be determine after the administration of the last dose on day 5.
  • Measurement of maximum oxygen consumption (VO2) [ Time Frame: Day 1 and Day 5 ]
    Change in maximum oxygen consumption after standard exercise testing.
  • PAT Index [ Time Frame: Day 1 and Day 5 ]
    Measurement of the PAT reactive hyperemia index by the EndoPAT device.
  • Myocardial Performance Index (MPI) [ Time Frame: Day 1 and Day 5 ]
    Myocardial Performance Index determined by echocardiogram.


Original Secondary Outcome: Same as current

Information By: Mezzion Pharma Co. Ltd

Dates:
Date Received: July 24, 2014
Date Started: July 2014
Date Completion:
Last Updated: April 24, 2015
Last Verified: April 2015