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

• Status: Completed
• Trial end date: 2019-12-21
• Target enrollment: 0
• Participant gender: All

Summary

With the 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

Inclusion Criteria:

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

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

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

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

Exclusion Criteria:

• Subjects 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.

• Subjects 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 C-SSRS.

• Subjects 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.

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

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

• Subjects with insulin-dependent diabetes mellitus.

• Subjects 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 IMP.

• Any history of significant bleeding or hemorrhagic tendencies.

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

• Subjects 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.

• Subjects who have a supine or standing diastolic blood pressure, after resting for at least 5 minutes ≥ 95 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 with a history of true allergic response to a medication or a history of dermatologic adverse reactions or anaphylaxis secondary to drug exposure.

• Subjects 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.