Autism Spectrum DisorderPhase 1NCT04382885

Cariprazine Pediatric ASD PK Study

A Phase 1 study testing Cariprazine in people with Autism Spectrum Disorder, run by AbbVie at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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). Read more about this study

Who is it for?: Ages 5 to 17 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Cariprazine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 3 sitesUnited States
Study dates: 26 Jun 2020to 10 Dec 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Atlanta Center for Medical Research /ID# 233576
Atlanta, Georgia, 30331
iResearch Atlanta, LLC /ID# 233614
Decatur, Georgia, 30030
Neuropsychiatric Research Center of Orange County /ID# 233663
Orange, California, 92868

Other trials in United States

About this study

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

Conditions: Autism Spectrum Disorder
Being tested: Cariprazine
Keywords: ASD, Autism
Medical subject headings: Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CariprazineDrug
Oral Solution

Study groups in NCT04382885
Study group	Role	What they receive
Cohort 1 (10-17 years)	Experimental	10 to 12 years: 0.75 mg/day cariprazine oral solution 13 to 17 years: 1.5 mg/day cariprazine oral solution Receives: Drug: Cariprazine
Cohort 2 (10-17 years)	Experimental	10 to 12 years: 1.5 mg/day cariprazine oral solution 13 to 17 years: 3.0 mg/day cariprazine oral solution Receives: Drug: Cariprazine
Cohort 3 (5-9 years)	Experimental	0.5 mg/day cariprazine oral solution Receives: Drug: Cariprazine
Cohort 4 (5-9 years)	Experimental	1.5 mg/day cariprazine oral solution Receives: Drug: Cariprazine

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events (AEs)
Measured: Up to 30 days after last visit or last dose for participants who discontinue early
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 30 days after last visit or last dose for participants who discontinue early
Incidence of AEs leading to discontinuation
Measured: Up to 30 days after last visit or last dose for participants who discontinue early
Percentage of participants with potentially clinically significant values in clinical laboratory assessments
Measured: Up to 84 days
Percentage of participants with potentially clinically significant values in vital signs assessments
Measured: Up to 84 days
Percentage of participants with potentially clinically significant values in ECG assessments
Measured: Up to 84 Days
Percentage of participants who have suicidal ideation or suicidal behaviors in C-SSRS assessments
Measured: Up to 84 Days
Percentage of participants with treatment-emergent parkinsonism in SAS assessments
Measured: Up to 84 Days
Percentage of participants with treatment-emergent akathisia in BARS assessments
Measured: Up to 84 days
Percentage of participants with potentially clinically significant values in ocular examination parameters
Measured: Screening to Day 84
Pharmacokinetics: Maximum plasma concentrations (Cmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42
Measured: Day 1 and Day 42
Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42
Measured: Day 1 and Day 42
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
Measured: Day 1 and Day 42
Pharmacokinetics: Terminal elimination half-life (T1/2) of cariprazine and its metabolites DCAR and DDCAR
Measured: Day 42 to Day 84
Pharmacokinetics: Minimum plasma concentrations (Cmin) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42
Measured: Day 42
Pharmacokinetics: Average plasma concentrations (Cavg) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42
Measured: Day 42
Pharmacokinetics: Apparent total clearance of cariprazine from plasma (CL/F) on Day 42
Measured: Day 42
Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of cariprazine
Measured: Day 42 to Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202010 Dec 2021

First posted11 May 2020
Study start26 Jun 2020
Primary completion10 Dec 2021
Study completion10 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04382885
Sponsor's protocol ID: 2000-103-009
Status last verified: Apr 2022
First submitted: 19 Mar 2020
Last updated: 12 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autism Spectrum Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Participants With Autism Spectrum Disorder Aged 5-17 Years
ClinicalTrials.gov ID: NCT04382885
Acronym / sponsor ID: 2000-103-009
Conditions: Autism Spectrum Disorder
Keywords: ASD, Autism
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 26 Jun 2020 (actual)
Primary completion: 10 Dec 2021 (actual)
Study completion: 10 Dec 2021 (actual)
First posted: 11 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1 (10-17 years)	Experimental	Drug: Cariprazine10 to 12 years: 0.75 mg/day cariprazine oral solution 13 to 17 years: 1.5 mg/day cariprazine oral solution
Cohort 2 (10-17 years)	Experimental	Drug: Cariprazine10 to 12 years: 1.5 mg/day cariprazine oral solution 13 to 17 years: 3.0 mg/day cariprazine oral solution
Cohort 3 (5-9 years)	Experimental	Drug: Cariprazine0.5 mg/day cariprazine oral solution
Cohort 4 (5-9 years)	Experimental	Drug: Cariprazine1.5 mg/day cariprazine oral solution

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CariprazineOral Solution	Drug	Cohort 1 (10-17 years), Cohort 2 (10-17 years), Cohort 3 (5-9 years), Cohort 4 (5-9 years)

Primary outcome

Incidence of Adverse Events (AEs)
Time frame: Up to 30 days after last visit or last dose for participants who discontinue early
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 30 days after last visit or last dose for participants who discontinue early
Incidence of AEs leading to discontinuation
Time frame: Up to 30 days after last visit or last dose for participants who discontinue early
Percentage of participants with potentially clinically significant values in clinical laboratory assessments
Time frame: Up to 84 days
Percentage of participants with potentially clinically significant values in vital signs assessments
Time frame: Up to 84 days
Percentage of participants with potentially clinically significant values in ECG assessments
Time frame: Up to 84 Days
Percentage of participants who have suicidal ideation or suicidal behaviors in C-SSRS assessments
Time frame: Up to 84 Days
Percentage of participants with treatment-emergent parkinsonism in SAS assessments
Time frame: Up to 84 Days
Percentage of participants with treatment-emergent akathisia in BARS assessments
Time frame: Up to 84 days
Percentage of participants with potentially clinically significant values in ocular examination parameters
Time frame: Screening to Day 84
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
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
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
Pharmacokinetics: Terminal elimination half-life (T1/2) of cariprazine and its metabolites DCAR and DDCAR
Time frame: Day 42 to Day 84
Pharmacokinetics: Minimum plasma concentrations (Cmin) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42
Time frame: Day 42
Pharmacokinetics: Average plasma concentrations (Cavg) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42
Time frame: Day 42
Pharmacokinetics: Apparent total clearance of cariprazine from plasma (CL/F) on Day 42
Time frame: Day 42
Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of cariprazine
Time frame: Day 42 to Day 84

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ALLERGAN INC. study director

Allergan

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cariprazine in people with Autism Spectrum Disorder, run by AbbVie at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Up to 30 days after last visit or last dose for participants who discontinue early). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04382885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.