drugset / 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
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2026-12-31
- Completion
- 2027-06-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 3 mg | Subcutaneous |
| Subject | Cariprazine | Small molecule | 22 mg | Subcutaneous |
| Subject | Cariprazine | Small molecule | 44 mg | Subcutaneous |