Clinical trial NCT04786730: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Attention-deficit Hyperactivity Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximal peak plasma concentration (Cmax)
timeFrame: 24 hours
measure: Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
timeFrame: 24 hours
measure: Apparent clearance and apparent volume of distribution of centanafadine on Day 14
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Arkansas
city: Decatur
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Georgia
city: Las Vegas
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Nevada
city: Oklahoma City
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Oklahoma
city: San Antonio
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Texas
Study officials:
References: