Back to resultsA Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MP-214 3mg
MP-214 6mg
MP-214 9mg
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Central Nervous System Agents
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
MP-214 3mg
MP-214 6mg
MP-214 9mg
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01626859
First Posted
June 19, 2012
Last Updated
April 8, 2021
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01626859
Brief Title
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
Official Title
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Central Nervous System Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MP-214 3mg
Arm Type
Experimental
Arm Title
MP-214 6mg
Arm Type
Experimental
Arm Title
MP-214 9mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MP-214 3mg
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
Intervention Type
Drug
Intervention Name(s)
MP-214 6mg
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
Intervention Type
Drug
Intervention Name(s)
MP-214 9mg
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame
Up to 24 weeks
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Sakai
State/Province
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
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