Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Pilot Phase 2a, Multicenter, Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules After Oral Administration in Pediatric Subjects (9 to 12 Years, Inclusive) With Attention-deficit Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081363
• Other study ID #: 405-201-00037
• Status: Completed
• Phase: Phase 2
• Start date: October 7, 2019
• Est. completion date: December 21, 2019

Study information

• Verified date: December 2022
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal tract. The information in this trial will support pediatric dose selection in future trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 21, 2019
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• Written informed consent obtained from a legally acceptable representative and assent obtained from the participant prior to the initiation of any trial-related procedures.

• Male or female participants 9 to 12 years of age, inclusive, at the time of informed consent.

• Participants with documented history of ADHD and confirmation of an ADHD prescription medication.

• Participant is judged by the investigator to be clinically stable and has not had any psychiatric hospitalizations within the past 12 weeks.

Exclusion Criteria:

• Participants with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient (IQ) < 70, or clinical evidence, or a social or school history that is suggestive of an intellectual disability.

• Participants who have any of the following:

• Significant risk of committing suicide based on history

• Current suicidal behavior

• Imminent risk of injury to self

• Active suicidal ideation

• Any lifetime history of suicidal behavior detected by the "Baseline/Screening" version of the Columbia-Suicide Severity Rating Scale (C-SSRS).

• Participants with a lifetime history of a substance use disorder (as determined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM-5] criteria), or current substance misuse including alcohol and benzodiazepines, but excluding caffeine and nicotine.

• Participants with hypothyroidism or hyperthyroidism or an abnormal result for free thyroxine (T4) at screening.

• Participants who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.

• Participants with insulin-dependent diabetes mellitus.

• Participants with epilepsy or a history of seizures or a history of severe head trauma or cerebrovascular disease.

• Any major surgery within 30 days prior to dosing with the investigational medicinal product (IMP).

• Any history of significant bleeding or hemorrhagic tendencies.

• Blood transfusion within 30 days prior to dosing with IMP.

• Participants with a positive drug screen for cocaine, marijuana (even if by prescription), or other illicit drugs, or alcohol, are excluded and may not be retested or rescreened.

• Participants who have a supine or standing diastolic blood pressure, after resting for at least 5 minutes = 95 mmHg.

• Participants 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.

• Participants with a history of true allergic response to a medication or a history of dermatologic adverse reactions or anaphylaxis secondary to drug exposure.

• Participants who do not tolerate venipuncture or have poor venous access that would cause difficulty when collecting blood samples.

• Relatives of the trial site employees cannot participate in the trial.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Centanafadine
Extended-release and immediate-release capsules.

Locations

Country	Name	City	State
United States	For additional information regarding sites, contact 844-687-8522	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Centanafadine		1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2
Primary	PK Parameter: Time to Maximum Plasma Concentration (Tmax) of Centanafadine		1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2
Primary	PK Parameter: Area Under Concentration-time Curve From Time 0 to 12 Hours Postdose (AUC0-12h) of Centanafadine		0 to 12 hours post dose on Day 1