Back to resultsA Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Primary Purpose
Attention-deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Centanafadine
Sponsored by
About this trial
This is an interventional treatment trial for Attention-deficit Hyperactivity Disorder
Eligibility Criteria
Key Inclusion Criteria:
- Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
- A diagnosis of any ADHD subtype based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
Key Exclusion Criteria:
- Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (medication, illicit drug use, etc); or subjects with a clinical presentation or history of psychotic symptoms.
- Subjects with developmental disorders, such as autism spectrum disorder.
- Subjects with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient < 70, or clinical evidence, or a social or school history that is suggestive of intellectual disability.
- Subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/ AIDS, or chronic hepatitis B or C.
- Subjects who have history of clinically significant tachycardia or hypertension.
Sites / Locations
- For additional information regarding sites, contact 844-687-8522
- For additional information regarding sites, contact 844-687-8522
- For additional information regarding sites, contact 844-687-8522
- For additional information regarding sites, contact 844-687-8522
- For additional information regarding sites, contact 844-687-8522
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label centanafadine
Arm Description
There will be multiple cohorts dosed with open-label centanafadine.
Outcomes
Primary Outcome Measures
Maximal peak plasma concentration (Cmax)
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Secondary Outcome Measures
Full Information
NCT ID
NCT04786730
First Posted
February 25, 2021
Last Updated
July 11, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04786730
Brief Title
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Official Title
A Phase 1b, Multicenter, Open-label, Multiple Ascending Dose Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Extended-release Capsules After Oral Administration in Pediatric Subjects (4 to 12 Years, Inclusive) With Attention-deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-label centanafadine
Arm Type
Experimental
Arm Description
There will be multiple cohorts dosed with open-label centanafadine.
Intervention Type
Drug
Intervention Name(s)
Centanafadine
Intervention Description
Doses of centanafadine will be taken once daily in the morning on Days 1 through 14. The fixed dose strengths will be administered according to body weight. Up to 12 subjects will be enrolled in the 9 to 12 years age cohorts (Cohorts 1 and 6), up to 8 subjects will be enrolled in each of the 6 to 8 years age cohorts (Cohorts 2 and 3), and up to 5 subjects will be enrolled in each of the 4 to 5 years age cohorts (Cohorts 4 and 5).
Primary Outcome Measure Information:
Title
Maximal peak plasma concentration (Cmax)
Time Frame
24 hours
Title
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Time Frame
24 hours
Title
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
A diagnosis of any ADHD subtype based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
Key Exclusion Criteria:
Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (medication, illicit drug use, etc); or subjects with a clinical presentation or history of psychotic symptoms.
Subjects with developmental disorders, such as autism spectrum disorder.
Subjects with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient < 70, or clinical evidence, or a social or school history that is suggestive of intellectual disability.
Subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/ AIDS, or chronic hepatitis B or C.
Subjects who have history of clinically significant tachycardia or hypertension.
Facility Information:
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
For additional information regarding sites, contact 844-687-8522
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
IPD Sharing URL
http://clinical-trials.otsuka.com
Learn more about this trial
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
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