Trials / Withdrawn
WithdrawnNCT05119894
A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
A Multicenter, Open-label, Clinical Pharmacology Trial to Determine the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the pharmacokinetics (PK), tolerability and safety of brexpiprazole LAI following a single administration in subjects with schizophrenia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexpiprazole LAI: Dose 1 | Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1 |
| DRUG | Brexpiprazole LAI: Dose 2 | Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2 |
| DRUG | Brexpiprazole LAI: Dose 3 | Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3 |
| DRUG | Brexpiprazole LAI: Dose 4 | Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4 |
Timeline
- Start date
- 2021-11-22
- Primary completion
- 2021-12-06
- Completion
- 2021-12-06
- First posted
- 2021-11-15
- Last updated
- 2022-04-28
Source: ClinicalTrials.gov record NCT05119894. Inclusion in this directory is not an endorsement.