Trial Outcomes & Findings for Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD) (NCT NCT04081363)
NCT ID: NCT04081363
Last Updated: 2023-01-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2
Results posted on
2023-01-13
Participant Flow
Participants took part in the study at 2 investigative sites in the United States from 07 October 2019 to 21 December 2019.
A total of 20 participants were screened and 13 participants were enrolled in the study to receive centanafadine as capsules or sprinkled onto applesauce.
Participant milestones
| Measure |
Swallowed Capsules Cohort
Participants swallowed two capsules of centanafadine (one containing a 50-milligram \[mg\] dose as extended release beads and other containing a 5-mg dose as immediate-release \[IR\] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Sprinkled Onto Applesauce Cohort
Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Swallowed Capsules Cohort
Participants swallowed two capsules of centanafadine (one containing a 50-milligram \[mg\] dose as extended release beads and other containing a 5-mg dose as immediate-release \[IR\] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Sprinkled Onto Applesauce Cohort
Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Swallowed Capsules Cohort
n=7 Participants
Participants swallowed two capsules of centanafadine (one containing a 50-milligram \[mg\] dose as extended release beads and other containing a 5-mg dose as immediate-release \[IR\] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Sprinkled Onto Applesauce Cohort
n=6 Participants
Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 1.0 • n=99 Participants
|
10.5 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
10.5 years
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2Population: Pharmacokinetic (PK) analysis set included all participants who received the single dose of centanafadine and had at least 1 postdose evaluable plasma concentration.
Outcome measures
| Measure |
Swallowed Capsules Cohort
n=6 Participants
Participants swallowed two capsules of centanafadine (one containing a 50-milligram \[mg\] dose as extended release beads and other containing a 5-mg dose as immediate-release \[IR\] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Sprinkled Onto Applesauce Cohort
n=6 Participants
Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Centanafadine
|
153 nanograms per milliliter (ng/mL)
Standard Deviation 51.4
|
129 nanograms per milliliter (ng/mL)
Standard Deviation 52.8
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2Population: PK analysis set included all participants who received the single dose of centanafadine and had at least 1 postdose evaluable plasma concentration.
Outcome measures
| Measure |
Swallowed Capsules Cohort
n=6 Participants
Participants swallowed two capsules of centanafadine (one containing a 50-milligram \[mg\] dose as extended release beads and other containing a 5-mg dose as immediate-release \[IR\] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Sprinkled Onto Applesauce Cohort
n=6 Participants
Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.
|
|---|---|---|
|
PK Parameter: Time to Maximum Plasma Concentration (Tmax) of Centanafadine
|
3.03 hours (h)
Interval 2.0 to 10.0
|
2.58 hours (h)
Interval 1.03 to 6.0
|
PRIMARY outcome
Timeframe: 0 to 12 hours post dose on Day 1Population: PK analysis set included all participants who received the single dose of centanafadine and had at least 1 postdose evaluable plasma concentration.
Outcome measures
| Measure |
Swallowed Capsules Cohort
n=6 Participants
Participants swallowed two capsules of centanafadine (one containing a 50-milligram \[mg\] dose as extended release beads and other containing a 5-mg dose as immediate-release \[IR\] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Sprinkled Onto Applesauce Cohort
n=6 Participants
Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.
|
|---|---|---|
|
PK Parameter: Area Under Concentration-time Curve From Time 0 to 12 Hours Postdose (AUC0-12h) of Centanafadine
|
962 h*ng/mL
Standard Deviation 320
|
828 h*ng/mL
Standard Deviation 346
|
Adverse Events
Swallowed Capsules Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sprinkled Onto Applesauce Cohort
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 |
Swallowed Capsules Cohort
n=7 participants at risk
Participants swallowed two capsules of centanafadine (one containing a 50-milligram \[mg\] dose as extended release beads and other containing a 5-mg dose as immediate-release \[IR\] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.
|
Sprinkled Onto Applesauce Cohort
n=6 participants at risk
Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.
|
|---|---|---|
|
General disorders
Vessel Puncture Site Bruise
|
14.3%
1/7 • Screening up to last follow-up (approximately 30 days)
Safety analysis set included all participants who received the single dose of centanafadine.
|
0.00%
0/6 • Screening up to last follow-up (approximately 30 days)
Safety analysis set included all participants who received the single dose of centanafadine.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 1-609-524-6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place