NCT04118127

A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses

A Multi-center, Open-label Clinical Pharmacology Trial to Investigate the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.

Detailed description

A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses. The trial comprises the single-dose period (Cohort 1) and the multiple-dose period (Cohort 2). The dose used in the multiple-dose period (Cohort 2) will be determined based on plasma drug concentrations obtained in the single-dose period (Cohort 1).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	2mg conventional tablet, once-weekly tablets	In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.

Timeline

• Start date: 2019-10-17
• Primary completion: 2021-02-16
• Completion: 2021-03-03
• First posted: 2019-10-08
• Last updated: 2024-08-05
• Results posted: 2024-08-05

Locations

1 site across 1 country: Japan