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Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

ConditionsSchizophreniaBipolar I DisorderMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMapi Pharma Ltd.

About this trial

The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only).

Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic/s or antidepressant/s other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg/day, with CGI-S score of 1-4.

Men and women aged 18-64 years (inclusive).

Body mass index (BMI) 18.5-35.

Disqualifiers

Subjects with schizophrenia with PANSS item scores of > 4 on any of the following: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.

Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.

Use of an investigational drug, and/or participation in clinical studies with an investigational product within 3 months prior to screening.

History or current cardiovascular or cerebrovascular disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cariprazine Depot

    Drug

    One single dose of 22 mg

  • Cariprazine Depot

    Drug

    One single dose of 44 mg

  • Cariprazine Depot MTD

    Drug

    Three monthly doses of MTD (maximum tolerated dose)

  • Oral Cariprazine 3 mg/day

    Drug

    Oral Cariprazine 3 mg/day for three months

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety, rate of adverse events (AEs)

Time frame
Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort
2

Plasma concentration of cariprazine and its active metabolites (DCAR, DDCAR)

Time frame
Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort

Secondary outcomes

1

Tolerability - Incidence and severity of injection site reactions

Time frame
Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort
2

Efficacy - Cohort 3: Positive and Negative Symptom Score (PANSS)

Time frame
Through study completion, up to 24 weeks for each subject in the 3rd cohort
3

Efficacy - Cohort 3: Clinical Global Impression Scale (CGI)

Time frame
Through study completion, up to 24 weeks for each subject in the 3rd cohort

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mapi Pharma Ltd.

Lead sponsor

Source ClinicalTrials.gov
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