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Completed

NCT Number: NCT04382885

Cariprazine Pediatric ASD PK Study

This study will be a multi-center, open-label, parallel-group, multiple-dose study in up to 24 male and female participants aged 5 through 17 years, inclusive, with Autism Spectrum Disorder (ASD). The 24 participants will be enrolled into 1 of 4 cohorts (6 participants per cohort).

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuropsychiatric Research Center of Orange County /ID# 233663, Orange, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria for ASD (Autism Spectrum Disorder) diagnosis.
  • Participants must have normal physical examination findings and clinical laboratory test results for their age group or abnormal results judged not clinically significant by the investigator.
  • Negative serum hCG (human chorionic gonadotropin) pregnancy test at screening (all female participants that have reached menarche).
  • BMI greater than the 5th percentile for age and gender based on CDC (Centers for Disease Control and Prevention) growth charts.
  • Participant (if reached his spermarche or her menarche), must agree to sexual abstinence or to use an approved birth control method for the full duration of participation in the study. The investigator and each participant will determine the appropriate method of contraception for the participant during their participation in the study.
  • Participant's parent(s)/legal representative(s) must be capable of giving signed informed consent , which includes compliance with the requirements and restrictions listed in the ICF and in the protocol as explained by the investigator. Written informed consent from the participant's parent(s)/legal representative(s) must be obtained prior to any study-related procedures.
  • Assent (unless local regulations require consent) must be obtained for all participants participating in the study.
  • Participant must have a parent or legal representative who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits. The caregiver can be the participant's parent(s)/legal representative(s). Written consent from the caregiver must be obtained.

Exclusion criteria

  • Current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition.
  • Diagnosis of intellectual disability (IQ < 70) documented by school record, neuropsychological testing or medical records.
  • Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before the Screening Visit.
  • Participant with an acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypo-thyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.
  • History of seizures, with the exception of febrile seizures.
  • History of tumor of the central nervous system.
  • Previously taken cariprazine or previously participated in an investigational study of cariprazine.
  • Participant is currently enrolled in an investigational drug or device study or participation in such a study within 3 months of Study Day 1.
  • Participation in a blood or plasma donation program within 60 or 30 days, respectively, prior to Study Day 1.
  • Positive UDS for substances of abuse at the Screening Visit or on Study Day -1.
  • Known allergy or sensitivity to the study intervention or its components.

Treatment and study plan

Cariprazine

Drug

Oral Solution

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 30 days after last visit or last dose for participants who discontinue early

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 30 days after last visit or last dose for participants who discontinue early

  3. Incidence of AEs leading to discontinuation

    Time frame: Up to 30 days after last visit or last dose for participants who discontinue early

  4. Percentage of participants with potentially clinically significant values in clinical laboratory assessments

    Time frame: Up to 84 days

  5. Percentage of participants with potentially clinically significant values in vital signs assessments

    Time frame: Up to 84 days

  6. Percentage of participants with potentially clinically significant values in ECG assessments

    Time frame: Up to 84 Days

  7. Percentage of participants who have suicidal ideation or suicidal behaviors in C-SSRS assessments

    Time frame: Up to 84 Days

  8. Percentage of participants with treatment-emergent parkinsonism in SAS assessments

    Time frame: Up to 84 Days

  9. Percentage of participants with treatment-emergent akathisia in BARS assessments

    Time frame: Up to 84 days

  10. Percentage of participants with potentially clinically significant values in ocular examination parameters

    Time frame: Screening to Day 84

  11. Pharmacokinetics: Maximum plasma concentrations (Cmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42

    Time frame: Day 1 and Day 42

  12. Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42

    Time frame: Day 1 and Day 42

  13. Pharmacokinetics: Area under the plasma concentration-time curve during the dosing interval (AUC0-tau) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42

    Time frame: Day 1 and Day 42

  14. Pharmacokinetics: Terminal elimination half-life (T1/2) of cariprazine and its metabolites DCAR and DDCAR

    Time frame: Day 42 to Day 84

  15. Pharmacokinetics: Minimum plasma concentrations (Cmin) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42

    Time frame: Day 42

  16. Pharmacokinetics: Average plasma concentrations (Cavg) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42

    Time frame: Day 42

  17. Pharmacokinetics: Apparent total clearance of cariprazine from plasma (CL/F) on Day 42

    Time frame: Day 42

  18. Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of cariprazine

    Time frame: Day 42 to Day 84

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Participants With Autism Spectrum Disorder Aged 5-17 Years

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 11, 2020
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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