A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine in Pediatric Subjects With Attention-deficit/Hyperactivity Disorder

NCT04398225 | Completed Phase 1 FDA Drug

• 1 other identifier: 405-201-00010
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• Maximal peak plasma concentration (Cmax)

  24 hours

• Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14

  24 hours

• Apparent clearance and apparent volume of distribution of centanafadine on Day 14

  24 hours

Study Arms (5)

Cohort 1 (9-12 y)

EXPERIMENTAL

Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days

Drug: Centanafadine

Cohort 2 (9-12 y)

EXPERIMENTAL

Centanafadine extended release capsule; 200 mg adult equivalent; twice daily for 14 days

Drug: Centanafadine

Cohort 3 (9-12 y)

EXPERIMENTAL

Centanafadine extended release capsule; 400 mg adult equivalent; twice daily for 14 days

Drug: Centanafadine

Cohort 4 (6-8 y)

EXPERIMENTAL

Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days

Drug: Centanafadine

Cohort 5 (4-5 y)

EXPERIMENTAL

Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days

Drug: Centanafadine

Interventions

Centanafadine DRUG

Extended release capsule

Cohort 1 (9-12 y); Cohort 2 (9-12 y); Cohort 3 (9-12 y); Cohort 4 (6-8 y); Cohort 5 (4-5 y)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
• Subjects must weight ≥ 13 kg.
• Subjects with 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).
• Subject is judged by the investigator to be clinically stable, and has not had any psychiatric hospitalizations within the past 12 weeks.
• Subjects and their caregivers must be able and willing to utilize the AiCure Platform for each daily dose.

You may not qualify if:

• 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 psychiatric or general medical condition(s) or direct effect of a substance.
• Subjects with developmental disorders, such as Autism Spectrum Disorder.
• Subjects with a history of at least mild intellectual disability as determined by IQ \< 70, clinical evidence, or a social or school history that is suggestive of intellectual disability.
• Subjects with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least 90 days prior to first dose of IMP) or an abnormal result for free T4 at screening.
• 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 with insulin dependent diabetes mellitus (i.e. any subjects using insulin)
• Subjects with epilepsy, Tourette's Disorder, or a history of seizures or a history of severe head trauma or cerebrovascular disease.
• Any major surgery within 30 days prior to the first dose of IMP.
• Any history of significant bleeding or hemorrhagic tendencies.
• Blood transfusions within 30 days prior to the first dose of IMP.
• Subjects who have supine or standing diastolic blood pressure, after resting for at least 5 minutes, \> 80 mmHg.
• Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days prior to screening or who participated in more than 2 interventional clinical trials within the past year. Subjects who have had any previous exposure to centanafadine.
• Subjects with a history of true allergic response to a medication or a history of dermatologic adverse reactions or anaphylaxis secondary drug exposure.
• Subjects with a history of allergic reaction or known or suspected sensitivity to any substance that is contained in the IMP formulation.
• Subjects who do not tolerate venipuncture or have poor venous access that would cause difficulty for collecting blood samples.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

For additional information regarding sites, contact 844-687-8522

Hollywood, Florida, 33024, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: June 11, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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

Locations

US (1)