Trial Outcomes & Findings for Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents (NCT NCT02201342)
NCT ID: NCT02201342
Last Updated: 2025-05-06
Results Overview
Number of subjects experiencing serious adverse events possibly or probably related to udenafil at doses of 37.5 mg daily, 37.5 mg twice daily, 87.5 mg daily, 87.5 mg twice daily, and 125 mg daily given over a five-day period.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
5 days
Results posted on
2025-05-06
Participant Flow
Participant milestones
| Measure |
Udenafil 37.5 mg QD
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg mg QD
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Only exercise testing
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
Baseline characteristics by cohort
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
Udenafil: Drug
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
Udenafil: Drug
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
Udenafil: Drug
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
Udenafil: Drug
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
Udenafil: Drug
|
No Drug
n=6 Participants
Cohort undergoing exercise test only
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 1.0 • n=99 Participants
|
16.2 years
STANDARD_DEVIATION 0.8 • n=107 Participants
|
15.0 years
STANDARD_DEVIATION 0.9 • n=206 Participants
|
15.5 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
16.5 years
STANDARD_DEVIATION 1.5 • n=31 Participants
|
16.2 years
STANDARD_DEVIATION 1.2 • n=30 Participants
|
15.8 years
STANDARD_DEVIATION 1.3 • n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
21 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
34 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
28 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
29 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 5 daysNumber of subjects experiencing serious adverse events possibly or probably related to udenafil at doses of 37.5 mg daily, 37.5 mg twice daily, 87.5 mg daily, 87.5 mg twice daily, and 125 mg daily given over a five-day period.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
n=6 Participants
Exercise only
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events Possibly or Probably Related to Udenafil
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of udenafil, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Udenafil: Cmax
|
94.8 ng/ml
Standard Deviation 46.2
|
152 ng/ml
Standard Deviation 46.1
|
277 ng/ml
Standard Deviation 107
|
506 ng/ml
Standard Deviation 188
|
438 ng/ml
Standard Deviation 173
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 5 (follow-up)Population: n= 4 to 5 for some measures
Evaluate the effect of udenafil on pharmacodynamic (PD) outcomes including: exercise capacity, vascular function, and echocardiographic measures of myocardial performance (MPI). The outcome measures (OM) are a difference between baseline (BL) and follow-up (FU) \[OM = FU-BL\].
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
n=6 Participants
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Effect of Udenafil on Pharmacodynamic (PD) Outcomes: Exercise Capacity
Max VO2 at max exercise effort
|
-0.8 ml/kg/min
Standard Deviation 1.7
|
-1.6 ml/kg/min
Standard Deviation 5.1
|
-1.4 ml/kg/min
Standard Deviation 2.5
|
0.2 ml/kg/min
Standard Deviation 5.0
|
0.9 ml/kg/min
Standard Deviation 2.6
|
-0.3 ml/kg/min
Standard Deviation 1.8
|
|
Evaluate the Effect of Udenafil on Pharmacodynamic (PD) Outcomes: Exercise Capacity
VO2 at anaerobic threshold
|
-0.5 ml/kg/min
Standard Deviation 4.1
|
0.1 ml/kg/min
Standard Deviation 1.0
|
-1.1 ml/kg/min
Standard Deviation 1.9
|
-1.7 ml/kg/min
Standard Deviation 2.1
|
1.2 ml/kg/min
Standard Deviation 1.9
|
0.1 ml/kg/min
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of metabolite DA-8164, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: Cmax
|
61.3 ng/ml
Standard Deviation 28.4
|
159 ng/ml
Standard Deviation 82.0
|
227 ng/ml
Standard Deviation 149
|
293 ng/ml
Standard Deviation 101
|
256 ng/ml
Standard Deviation 32.5
|
—
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of udenafil, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Udenafil: Tmax
|
2.25 hr
Standard Deviation 0.880
|
1.50 hr
Standard Deviation 0.837
|
2.11 hr
Standard Deviation 0.735
|
1.25 hr
Standard Deviation 0.274
|
1.58 hr
Standard Deviation 0.665
|
—
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of udenafil, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Udenafil: T-1/2
|
12.9 hr
Standard Deviation 3.12
|
13.3 hr
Standard Deviation 1.48
|
12.6 hr
Standard Deviation 0.897
|
10.4 hr
Standard Deviation 1.19
|
11.1 hr
Standard Deviation 2.80
|
—
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of udenafil, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Udenafil: AUC (0-tau)
|
834 hr*ng/ml
Standard Deviation 403
|
1050 hr*ng/ml
Standard Deviation 387
|
2200 hr*ng/ml
Standard Deviation 459
|
3350 hr*ng/ml
Standard Deviation 796
|
3420 hr*ng/ml
Standard Deviation 1800
|
—
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of udenafil, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Udenafil: CLSS/F
|
53.3 l/hr
Standard Deviation 21.3
|
39.9 l/hr
Standard Deviation 14.2
|
41.1 l/hr
Standard Deviation 7.76
|
27.2 l/hr
Standard Deviation 5.39
|
43.3 l/hr
Standard Deviation 16.8
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 5 (follow-up)Population: n= 4 to 5 for some measures
Evaluate the effect of udenafil on pharmacodynamic (PD) outcomes including: exercise capacity, vascular function, and echocardiographic measures of myocardial performance (MPI). The outcome measures (OM) are a difference between baseline (BL) and follow-up (FU, Day-5) \[OM = FU-BL\]. Endothelial pulse amplitude tonometry (Endo-PAT) is a technique for the non-invasive assessment of peripheral vascular function. In adults, Endo-PAT has been demonstrated to identify those with coronary artery dysfunction and to correlate with brachial artery reactivity testing. Endo-PAT use in children has been more limited, but has shown excellent reproducibility. Reactive hyperemia index (RHI), a measure of the hyperemic response adjusted for baseline blood flow, is a measure of vascular function. A higher value denotes better, or more healthy, vascular (endothelial) function. The data represents a change in the index value so there is no minimum or maximum value that can be represented on a scale.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=5 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=4 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Effect of Udenafil on Pharmacodynamic (PD) Outcomes: Vascular Function [Change in Natural Log Transformed Reactive Hyperemia Index (RHI)]
|
0.3 Change in natural log Transformed RHI
Standard Deviation 0.47
|
-0.07 Change in natural log Transformed RHI
Standard Deviation 0.17
|
0.07 Change in natural log Transformed RHI
Standard Deviation 0.22
|
-0.03 Change in natural log Transformed RHI
Standard Deviation 0.20
|
-0.10 Change in natural log Transformed RHI
Standard Deviation 0.38
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 5 (follow-up)Population: n= 4 to 5 for some measures
The outcome measures (OM) are a difference between baseline (BL) and follow-up (FU, Day-5). Change in the MPI from baseline to Day 5 is determined by velocities from blood pool Doppler of the inflow and outflow tract of the dominant ventricle. The measure is the ratio of the sum of isovolumetric contraction time and isovolumetric relaxation time, divided by ventricular ejection time. A lower value is consistent with a more efficient ventricle (better function). A value of zero indicates that there is no isovolumetric contraction or relaxation and, while physiologically implausible, would be consistent with a perfectly efficient ventricle. In general, a decrease in the MPI corresponds to more efficient (better) ventricular function, while an increase in MPI corresponds to less efficient (worse) ventricular function. The data represents a change in the index value so there is no minimum or maximum value that can be represented on a scale.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=5 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=5 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=5 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Absolute Change in Blood Pool Myocardial Performance Index (MPI)
|
-0.052 Change in blood pool MPI
Standard Deviation 0.166
|
-0.003 Change in blood pool MPI
Standard Deviation 0.102
|
-0.076 Change in blood pool MPI
Standard Deviation 0.144
|
-0.118 Change in blood pool MPI
Standard Deviation 0.090
|
-0.054 Change in blood pool MPI
Standard Deviation 0.180
|
—
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of metabolite DA-8164, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: Tmax
|
3.08 hr
Standard Deviation 1.56
|
2.09 hr
Standard Deviation 1.62
|
3.19 hr
Standard Deviation 0.949
|
2.58 hr
Standard Deviation 0.917
|
3.84 hr
Standard Deviation 1.33
|
—
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of metabolite DA-8164, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=5 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=5 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=4 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: T-1/2
|
15.9 hr
Standard Deviation 4.90
|
14.4 hr
Standard Deviation 2.31
|
15.3 hr
Standard Deviation 2.73
|
12.6 hr
Standard Deviation 2.25
|
14.7 hr
Standard Deviation 2.30
|
—
|
SECONDARY outcome
Timeframe: Day 5, zero to 48 hours after the last dosePopulation: The No Drug Group is not eligible for PK analysis.
Evaluate the pharmacokinetic (PK) profile of metabolite DA-8164, by weight, age, and gender in adolescents with Fontan physiology at multiple dosing levels.
Outcome measures
| Measure |
Udenafil 37.5 mg QD
n=6 Participants
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 Participants
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 Participants
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 Participants
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=5 Participants
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
Exercise only
|
|---|---|---|---|---|---|---|
|
Evaluate the Pharmacokinetic (PK) Profile of Metabolite DA-8164: AUC(0-tau)
|
881 hr*ng/ml
Standard Deviation 375
|
1290 hr*ng/ml
Standard Deviation 710
|
2910 hr*ng/ml
Standard Deviation 1880
|
2410 hr*ng/ml
Standard Deviation 568
|
3470 hr*ng/ml
Standard Deviation 471
|
—
|
Adverse Events
Udenafil 37.5 mg QD
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Udenafil 37.5 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Udenafil 87.5 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Udenafil 87.5 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Udenafil 125 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
No Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Udenafil 37.5 mg QD
n=6 participants at risk
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 participants at risk
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 participants at risk
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 participants at risk
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 participants at risk
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
n=6 participants at risk
Exercise only
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Altered mental status/mood altered
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
Other adverse events
| Measure |
Udenafil 37.5 mg QD
n=6 participants at risk
Udenafil 37.5 mg tablet once daily for 5 days
|
Udenafil 37.5 mg BID
n=6 participants at risk
Udenafil 37.5 mg tablet twice daily for 5 days
|
Udenafil 87.5 mg QD
n=6 participants at risk
Udenafil 87.5 mg tablet once daily for 5 days
|
Udenafil 87.5 mg BID
n=6 participants at risk
Udenafil 87.5 mg tablet twice daily for 5 days
|
Udenafil 125 mg QD
n=6 participants at risk
Udenafil 125 mg tablet once daily for 5 days
|
No Drug
n=6 participants at risk
Exercise only
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 4
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Flushing
|
16.7%
1/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
66.7%
4/6 • Number of events 4
|
33.3%
2/6 • Number of events 7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Headache
|
50.0%
3/6 • Number of events 9
|
66.7%
4/6 • Number of events 6
|
66.7%
4/6 • Number of events 9
|
66.7%
4/6 • Number of events 12
|
83.3%
5/6 • Number of events 14
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
3/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 5
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER