A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Tanabe Pharma Corporation
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Study Overview
Brief Summary
The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
MP-214 9mg
Intervention: MP-214 9mg (Drug)
MP-214 3mg
Intervention: MP-214 3mg (Drug)
MP-214 6mg
Intervention: MP-214 6mg (Drug)
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.
Secondary Outcomes
No secondary outcomes reported