Trial Outcomes & Findings for Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD (NCT NCT02470234)
NCT ID: NCT02470234
Last Updated: 2021-11-24
Results Overview
Maximum plasma concentration
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Results posted on
2021-11-24
Participant Flow
It was a parallel design study, where subjects were recruited from July 02, 2016 - July 19, 2017. Eligible subjects received one capsule of Methylphenidate HCl ER (10, 15, 20, 30, or 40 mg) on only one of the 3 dosing days depending on number of subjects recruited up each particular dosing day. Only 1 site was able to recruit subjects.
Participant milestones
| Measure |
Methylphenidate HCl ER 10 mg
Subjects received a single dose of Methylphenidate HCl ER 10 mg . This dose was equivalent to their current total daily methylphenidate dose.
|
Methylphenidate HCl ER 15 mg
Subjects received a single dose of Methylphenidate HCl ER 15 mg . This dose was equivalent to their current total daily methylphenidate dose.
|
Methylphenidate HCl ER 20 mg
Subjects received a single dose of Methylphenidate HCl ER 20 mg . This dose was equivalent to their current total daily methylphenidate dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
2
|
|
Overall Study
COMPLETED
|
5
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD
Baseline characteristics by cohort
| Measure |
Methylphenidate HCl ER 10 mg
n=5 Participants
Subjects received a single dose of Methylphenidate HCl ER 10 mg
|
Methylphenidate HCl ER 15 mg
n=3 Participants
Subjects received a single dose of Methylphenidate HCl ER 15 mg
|
Methylphenidate HCl ER 20 mg
n=2 Participants
Subjects received a single dose of Methylphenidate HCl ER 20 mg
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.0 Months
STANDARD_DEVIATION 8.03 • n=5 Participants
|
63.3 Months
STANDARD_DEVIATION 5.51 • n=7 Participants
|
70.5 Months
STANDARD_DEVIATION 0.71 • n=5 Participants
|
63.6 Months
STANDARD_DEVIATION 7.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
BMI
|
15.3 kg/m^2
STANDARD_DEVIATION 0.55 • n=5 Participants
|
15.3 kg/m^2
STANDARD_DEVIATION 0.98 • n=7 Participants
|
15.3 kg/m^2
STANDARD_DEVIATION 2.26 • n=5 Participants
|
15.3 kg/m^2
STANDARD_DEVIATION 0.96 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per protocol
Maximum plasma concentration
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=5 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=2 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
Cmax
|
8.07 ng/mL
Standard Deviation 1.702
|
10.09 ng/mL
Standard Deviation 0.620
|
15.45 ng/mL
Standard Deviation 1.061
|
PRIMARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per Protocol
Area under the plasma concentration versus time curve (calculated to the last measurable observation). AUC: Area Under the Curve
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=5 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=2 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
AUC(0-t)
|
89.18 ng*hr/mL
Standard Deviation 25.047
|
118.49 ng*hr/mL
Standard Deviation 18.211
|
155.95 ng*hr/mL
Standard Deviation 35.209
|
PRIMARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per protocol. (n=1) Standard Deviation was not estimable.
Area under the plasma concentration versus time curve, extrapolated to infinity. AUC: Area Under the Curve
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
AUC(0-inf)
|
105.26 ng*hr/mL
Standard Deviation 21.831
|
140.68 ng*hr/mL
Standard Deviation 0
|
144.26 ng*hr/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per Protocol.
Dose-normalized AUC0-t. AUC: Area Under the Curve
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=5 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=2 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
AUC/D
|
8.92 ng*hr/mL/mg
Standard Deviation 2.505
|
7.90 ng*hr/mL/mg
Standard Deviation 1.214
|
7.80 ng*hr/mL/mg
Standard Deviation 1.760
|
PRIMARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per protocol. (n=1) Standard Deviation was not estimable.
Apparent clearance. CL: Clearance
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
CL/F
|
97.51 L/h
Standard Deviation 18.095
|
106.63 L/h
Standard Deviation 0
|
138.64 L/h
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per protocol. (n=1) Standard Deviation was not estimable.
Volume of distribution
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
V(Dss)/F
|
682.49 L
Standard Deviation 182.605
|
1952.17 L
Standard Deviation 0
|
1396.96 L
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per Protocol
Dose-normalized Cmax
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=5 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=2 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
Cmax/Dose
|
0.81 ng/mL/mg
Standard Deviation 0.170
|
0.67 ng/mL/mg
Standard Deviation 0.041
|
0.77 ng/mL/mg
Standard Deviation 0.053
|
SECONDARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per Protocol
Time to peak plasma concentration
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=5 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=2 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
Tmax
|
2.0 h
Interval 1.0 to 3.0
|
3.0 h
Interval 3.0 to 12.0
|
2.0 h
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per Protocol. (n=1) Standard Deviation was not estimable.
Elimination half-life
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
T1/2
|
4.80 h
Standard Deviation 0.466
|
12.69 h
Standard Deviation 0
|
6.98 h
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: Per Protocol. (n=1) Standard Deviation was not estimable
Terminal elimination constant
Outcome measures
| Measure |
Methylphenidate HCl ER 10 mg
n=3 Participants
Active drug, administered once
Methylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 15 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
Methylphenidate HCl ER 20 mg
n=1 Participants
Active drug, administered once
Methylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions
|
|---|---|---|---|
|
Kel
|
0.15 h-1
Standard Deviation 0.015
|
0.05 h-1
Standard Deviation 0
|
0.10 h-1
Standard Deviation 0
|
Adverse Events
Methylphenidate HCl ER 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Methylphenidate HCl ER 15 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylphenidate HCl ER 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methylphenidate HCl ER 10 mg
n=5 participants at risk
Subjects received a single dose of Methylphenidate HCl ER 10 mg
|
Methylphenidate HCl ER 15 mg
n=3 participants at risk
Subjects received a single dose of Methylphenidate HCl ER 15 mg
|
Methylphenidate HCl ER 20 mg
n=2 participants at risk
Subjects received a single dose of Methylphenidate HCl ER 20 mg
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • From check in until 24 hours post dose
Definitions for SAEs and AEs do not differ from ClinicalTrials.gov definitions
|
0.00%
0/3 • From check in until 24 hours post dose
Definitions for SAEs and AEs do not differ from ClinicalTrials.gov definitions
|
0.00%
0/2 • From check in until 24 hours post dose
Definitions for SAEs and AEs do not differ from ClinicalTrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place