A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

Tanabe Pharma Corporation38 enrolled

Overview

The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

MP-214 3mgDRUG

Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.

MP-214 6mgDRUG

Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.

MP-214 9mgDRUG

Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent obtained from the patient before the initiation of any study-specific procedures * Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia * Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG) Exclusion Criteria: * Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Unnamed facility

Sakai, Osaka, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame: Up to 24 weeks

Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

Time frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

Time frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

Time frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

Data from ClinicalTrials.gov

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