Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to

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Brief Title

Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders

Official Title

A Phase 1, Single-dose, Sequential Cohort, Nonrandomized Crossover Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Oral Brexpiprazole in Children (6 to< 13 Years Old) With Central Nervous System Disorders

Brief Summary

      A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages
      6 to <13 years with CNS disorders.
    

Detailed Description

      A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics,
      safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders
      who are receiving antipsychotic treatment for their medical condition.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum Plasma Concentration (Cmax) [PK]

Secondary Outcome

 Treatment-Emergent Adverse Events (TEAES) [Safety]

Condition

ADHD

Intervention

Brexpiprazole

Study Arms / Comparison Groups

 10 to <13 Years of Age
Description:  Two doses will be administered with a washout period of 14 days between the first dose of 1.5 mg the second dose of 3 mg.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

October 10, 2017

Completion Date

May 21, 2018

Primary Completion Date

May 21, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female subjects between 6 and 12 years of age

          -  Subjects with CNS disorders including, but not limited to, ADHD, autism spectrum
             disorders, bipolar I disorder (subjects 10 to 12 years old only for bipolar), conduct
             disorder, oppositional defiant disorder, or any psychotic disorder and who are
             receiving antipsychotic treatment for their medical condition. Subjects' diagnoses
             will be determined by the Diagnostic and Statistical Manual of Mental Disorders, 5th
             Edition (DSM-5) criteria and confirmed at screening using the Kiddie Schedule for
             Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).

          -  Subjects must be considered psychiatrically/medically appropriate for participation in
             a clinical trial in which they will receive two doses of an antipsychotic medication.

          -  Subjects with good physical health, as determined by no clinically significant
             deviation from normal for all of the following, prior to enrollment in the trial:

               1. Medical history

               2. Clinical laboratory determination

               3. ECGs

               4. Physical examinations

          -  Subjects who are within the 5th to 95th percentile for gender-specific BMI for age
             from the Centers for Disease Control and Prevention growth charts and weight at least
             15 kg (approx. 33 lbs)

          -  Ability to commit to remain fully abstinent or use 2 approved methods of birth control
             during the trial for 21 (± 2) days following the last dose of IMP for sexually active
             females of childbearing potential.

          -  Ability, in the opinion of the PI, of the subject and the subject's legally acceptable
             representative or caregiver(s) to understand the nature of the trial and follow
             protocol requirements, including all of the following:

               1. Comply with prescribed dosage regimens and tablet ingestion, as well as the
                  discontinuation of prohibited concomitant medications

               2. Reliably return for scheduled visits

               3. To be reliably rated on assessment scales

        Exclusion Criteria:

          -  Subjects with a clinical presentation or history that is consistent with delirium,
             dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that
             are better accounted for by another general medical condition(s) other than those
             listed in the second inclusion criterion above, or direct effect of a substance (ie,
             medication, illicit drug use, etc.).

          -  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 who have any of the following:

               1. A significant risk of committing suicide based on history and the principal
                  investigator's clinical judgment, or routine psychiatric status examination

               2. Current suicidal behavior

               3. Imminent risk of injury; active suicidal ideation

               4. Any lifetime history of suicidal behavior detected by the Children's
                  Baseline/Screening version of the C-SSRS.

          -  Subjects with a lifetime history of a substance use disorder (as determined by the
             DSM-5 criteria), or current substance misuse including alcohol and benzodiazepines,
             but excluding caffeine and nicotine.

          -  Subjects who currently have clinically significant neurological, hepatic, renal,
             metabolic, hematological, immunological, cardiovascular, pulmonary, or
             gastrointestinal disorders such as any history of myocardial infarction, congestive
             heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic
             hepatitis B or C. Medical conditions that are minor or well-controlled may be
             considered acceptable if the condition does not expose the subject to an undue risk of
             significant adverse event or interfere with assessments during the course of the
             trial.

          -  Subjects with insulin dependent diabetes mellitus (IDDM) are excluded. Subjects with
             non-IDDM may be eligible for the trial if their condition is determined to be stable.

          -  Subjects with epilepsy or a history of seizures (except for a single seizure episode,
             for instance childhood febrile seizure or post traumatic) or a history of severe head
             trauma or cerebrovascular disease (eg, stroke, transient ischemic attack, etc.).

          -  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 first dose of 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 supine or standing diastolic blood pressure, after resting for at
             least 5 minutes, ≥ 95 mmHg.

          -  Subjects who have had a dose of depot antipsychotics within 6 months of screening.

          -  Consumption of alcohol or grapefruit, grapefruit juice, Seville oranges, or Seville
             orange juice within 72 hours prior to the first dose of IMP and throughout the trial

          -  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 neuroleptic malignant syndrome or hypersensitivity to
             atypical antipsychotics.

          -  Subjects with a history of true allergic (i.e. not intolerance) response to more than
             one class of medications.

          -  Subjects with a history of allergic reaction or a known or suspected sensitivity to
             any substance that is contained in the IMP formula.

          -  Subjects who do not tolerate venipuncture or have poor venous access that would cause
             difficulty for collecting blood samples.

          -  Prisoners or subjects who are compulsorily detained (e.g. juvenile detention,
             court-mandated treatment) for any reason.

          -  Inability to tolerate oral medication or swallow tablets.
      

Gender

All

Ages

6 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03292848

Organization ID

331-201-00103


Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

 H. Lundbeck A/S

Study Sponsor

, , 


Verification Date

June 2018