NCT04786730CompletedPhase 1
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
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country50 target enrollmentStarted: March 9, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Maximal peak plasma concentration (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
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.
Arms & Interventions
Open-label centanafadine
Experimental
There will be multiple cohorts dosed with open-label centanafadine.
Intervention: Centanafadine (Drug)
Outcomes
Primary Outcomes
Maximal peak plasma concentration (Cmax)
Time Frame: 24 hours
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Time Frame: 24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Time Frame: 24 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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