CompletedPhase 2/3

A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

Japan38 participantsStarted 2012-05

Plain-language summary

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

Who can participate

Age range20 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Up to 24 weeks

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

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT01626859

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

Results submitted2021-01-11

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range20 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to 24 weeks

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

Timeframe: 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

Timeframe: 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

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