clinical trial · NCT07185815
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
SchizophreniaBipolar I DisorderMajor Depressive DisorderCariprazine DepotCariprazine DepotCariprazine Depot MTDOral Cariprazine 3 mg/day
brief summary
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.
started
Aug 1, 2025
primary completion
Dec 31, 2026
completion
Jun 3, 2027
last updated
May 1, 2026
official title
A Prospective, Dose Escalating, Open Label, Multi-center, Phase I/IIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.
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