Phase 2
Completed N=36
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
Single Ventricle Heart Disease After Fontan Surgery
Source: ClinicalTrials.gov NCT02201342 ↗
Enrolled (actual)
36
Serious AEs
2.8%
Results posted
May 2025
Primary outcomePrimary: Number of Subjects With Serious Adverse Events Possibly or Probably Related to Udenafil — 0; 0; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious Adverse Events Possibly or Probably Related to Udenafil |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Udenafil: Cmax |
94.8; 152; 277; 506; 438 | — |
| SECONDARY Evaluate the Effect of Udenafil on Pharmacodynamic (PD) Outcomes: Exercise Capacity |
-0.8; -1.6; -1.4; 0.2; 0.9; -0.3 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: Cmax |
61.3; 159; 227; 293; 256 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Udenafil: Tmax |
2.25; 1.50; 2.11; 1.25; 1.58 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Udenafil: T-1/2 |
12.9; 13.3; 12.6; 10.4; 11.1 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Udenafil: AUC (0-tau) |
834; 1050; 2200; 3350; 3420 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Udenafil: CLSS/F |
53.3; 39.9; 41.1; 27.2; 43.3 | — |
| SECONDARY Evaluate the Effect of Udenafil on Pharmacodynamic (PD) Outcomes: Vascular Function [Change in Natural Log Transformed Reactive Hyperemia Index (RHI)] |
0.3; -0.07; 0.07; -0.03; -0.10 | — |
| SECONDARY Absolute Change in Blood Pool Myocardial Performance Index (MPI) |
-0.052; -0.003; -0.076; -0.118; -0.054 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: Tmax |
3.08; 2.09; 3.19; 2.58; 3.84 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: T-1/2 |
15.9; 14.4; 15.3; 12.6; 14.7 | — |
| SECONDARY Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: AUC(0-tau) |
881; 1290; 2910; 2410; 3470 | — |
Eligibility Criteria
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 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.
- Hospitalization for acute decompensated heart failure within the 12 months preceding study enrollment.
- A diagnosis of active protein losing enteropathy or plastic bronchitis.
- Active evaluation or listing for heart transplant.
- History of use of a phosphodiesterase type 5 inhibitor within three months of study enrollment.
- Concurrent illness that, in the opinion of the investigator, precludes participation.
- Current therapy with alpha-blockers or nitrates.
- Pregnancy at the time of enrollment.
- Latex allergy
Data sourced from ClinicalTrials.gov (NCT02201342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.