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

• ClinicalTrials.gov Identifier: NCT06036108
• Recruitment Status: Recruiting
• First Posted: September 13, 2023
• Last Update Posted: October 17, 2023
• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Otsuka Pharmaceutical Co., Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: OPC-34712FUM/ Brexpiprazole fumarate	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 3, 2023
• Estimated Primary Completion Date: January 2025
• Estimated Study Completion Date: January 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fasting-state administration group; Brexpiprazole QW formulation in a fasting-state administration	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.
Experimental: Fed-state administration group; Brexpiprazole QW formulation in a fed-state administration	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.

Outcome Measures

Primary Outcome Measures :

1. Maximum plasma concentration (Cmax) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state [ Time Frame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose ]
   To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state
2. Area Under Curve (AUC) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state [ Time Frame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose ]
   To evaluate AUC of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed consent
• Patients who are able to be hospitalized for the protocol-defined hospitalization period
• Patients with a body mass index [BMI = body weight (kg)/height (m)²] of 18.5 kg/m² or higher and lower than 35.0 kg/m² at screening
• Patients who, in the judgment of the investigator, have stable psychotic symptoms maintained by administration of an antipsychotic within the dosing range indicated below, before commencement of IMP administration [Upper limit of dose and regimen] Antipsychotic medication comprising no more than 2 active components, and a daily dose equivalent to ≤600 mg/day of chlorpromazine
• Patients who are able to finish the high-fat meal specified in this protocol within 20 minutes

Exclusion Criteria:

• Patients with a concurrent mental disorder besides schizophrenia who are judged by the investigator to be unsuitable for participation in the trial
• Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of investigational medicinal product (IMP) administration

• Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior

  • Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding C-SSRS suicidal ideation at screening (for the past 6 months) or at the Period 1 baseline examination (since the last assessment)
  • Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at the Period 1 baseline examination (since the last assessment)
  • Patients who present a serious risk of suicide based on the judgment of the investigator
• Patients who have previously undergone gastrointestinal surgery that could affect PK evaluation
• Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and PK assessments.
• Patients who are using clozapine at the time of informed consent
• Patients whose clinical symptoms have worsened to the point where use of prohibited concomitant therapy or medication is required during the washout period for prior medication
• Patients whose cytochrome P450 2D6 (CYP2D6) phenotype is judged to be either poor metabolizers (PM) or Unknown based on the results of CYP2D6 genotyping at screening

Contacts and Locations

Contacts

Contact: Drug Information Center; +81-3-6361-7314

Locations

Japan

Rainbow & Sea Hospital; Recruiting

Saga-shi, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

• Study Director: Takehisa Matsumaru; Otsuka Pharmaceutical Co., Ltd.

More Information

• Responsible Party: Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06036108
• Other Study ID Numbers: 331-102-00151
• First Posted: September 13, 2023
• Last Update Posted: October 17, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Brexpiprazole; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Dopamine Agonists; Dopamine Agents