NCT02201342

Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mezzion Pharma Co. Ltd · Industry
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Single Ventricle Heart Disease After Fontan Surgery

Interventions

Type	Name	Description
DRUG	Udenafil	Drug

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-07-28
• Last updated: 2025-05-06
• Results posted: 2025-05-06

Locations

6 sites across 2 countries: United States, Canada