NCT06036108

Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

A Multicenter, Randomized, Open-label, 2-arm, 2-period Crossover Trial to Investigate the Effects of Food on the Pharmacokinetics of a Single Dose of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	OPC-34712FUM/ Brexpiprazole fumarate	In Period 1, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered at least 10 hours of fasting. In Period 2, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal.
DRUG	OPC-34712FUM/ Brexpiprazole fumarate	In Period 1, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal. In Period 2, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered following at least 10 hours of fasting.

Timeline

• Start date: 2023-10-03
• Primary completion: 2025-03-18
• Completion: 2025-04-08
• First posted: 2023-09-13
• Last updated: 2026-02-11
• Results posted: 2026-02-11

Locations

1 site across 1 country: Japan