Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Centanafadine
Intervention description: Extended-release and immediate-release capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All the participants received only centanafadine but divided into 2 arm groups based on administration (as capsules or drug sprinkled onto applesauce).
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 9 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD

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.
    

Eligibility criteria:

        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.