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A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

NCT05119894 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-04-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takehisa Matsumaru · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-22
Primary Completion
2021-12-06
Completion
2021-12-06

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05119894 on ClinicalTrials.gov