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

PHASE1CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

October 3, 2023

Primary Completion Date

March 18, 2025

Study Completion Date

April 8, 2025

Conditions
Schizophrenia
Interventions
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.

Trial Locations (1)

Unknown

Rainbow & Sea Hospital, Saga

All Listed Sponsors
lead

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY