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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
One single dose of 22 mg
One single dose of 44 mg
Three monthly doses of MTD (maximum tolerated dose)
Oral Cariprazine 3 mg/day for three months
Mapi Pharma Investigational Site IN-101
Ahmedabad, India
RECRUITINGMapi Pharma Investigational Site IN-102
Ahmedabad, India
RECRUITINGMapi Pharma Investigational Site IL-004
Beersheba, Israel
RECRUITINGMapi Pharma Investigational Site IL-003
Ness Ziona, Israel
RECRUITINGMapi Pharma Investigational Site IL-005
Ramat Gan, Israel
RECRUITINGMapi Pharma Investigational Site IL-001
Tel Aviv, Israel
RECRUITINGSafety, 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
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
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
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
Efficacy - Cohort 3: Clinical Global Impression Scale (CGI)
Time frame: Through study completion, up to 24 weeks for each subject in the 3rd cohort
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