Schizophrenia
Conditions
Keywords
Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Central Nervous System Agents
Brief summary
The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.
Interventions
DRUGMP-214 3mg
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
DRUGMP-214 6mg
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
DRUGMP-214 9mg
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 24 weeks |
| Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | 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 | 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 | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MP-214 3mg MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks. | 11 |
| MP-214 6mg MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks. | 16 |
| MP-214 9mg MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks. | 11 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 2 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 2 |
Baseline characteristics
| Characteristic | MP-214 3mg | MP-214 6mg | MP-214 9mg | Total |
|---|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 13.2 | 43.1 years STANDARD_DEVIATION 10.7 | 43.2 years STANDARD_DEVIATION 13.3 | 43.1 years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 5 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 15 / 16 | 11 / 11 |
| serious Total, serious adverse events | 0 / 11 | 2 / 16 | 0 / 11 |
Outcome results
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MP-214 3mg | 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 | M7 (desmethyl cariprazine) | 50.03 ng*h/mL | Standard Deviation 31.19 |
| MP-214 3mg | 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 | Unchanged MP-214 | 155.96 ng*h/mL | Standard Deviation 71.99 |
| MP-214 3mg | 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 | M6 (didesmethyl cariprazine) | 352.03 ng*h/mL | Standard Deviation 252.78 |
| MP-214 6mg | 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 | M7 (desmethyl cariprazine) | 115.26 ng*h/mL | Standard Deviation 23.47 |
| MP-214 6mg | 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 | Unchanged MP-214 | 358.37 ng*h/mL | Standard Deviation 85.24 |
| MP-214 6mg | 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 | M6 (didesmethyl cariprazine) | 800.21 ng*h/mL | Standard Deviation 206.73 |
| MP-214 9mg | 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 | Unchanged MP-214 | 466.36 ng*h/mL | Standard Deviation 154.55 |
| MP-214 9mg | 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 | M6 (didesmethyl cariprazine) | 1140.42 ng*h/mL | Standard Deviation 711.59 |
| MP-214 9mg | 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 | M7 (desmethyl cariprazine) | 163.31 ng*h/mL | Standard Deviation 72.72 |
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MP-214 3mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M7 (desmethyl cariprazine) | 2.624 ng/mL | Standard Deviation 1.521 |
| MP-214 3mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Unchanged MP-214 | 10.23 ng/mL | Standard Deviation 4.691 |
| MP-214 3mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M6 (didesmethyl cariprazine) | 15.77 ng/mL | Standard Deviation 10.88 |
| MP-214 6mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M7 (desmethyl cariprazine) | 5.963 ng/mL | Standard Deviation 1.593 |
| MP-214 6mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Unchanged MP-214 | 22.65 ng/mL | Standard Deviation 4.181 |
| MP-214 6mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M6 (didesmethyl cariprazine) | 35.94 ng/mL | Standard Deviation 7.995 |
| MP-214 9mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Unchanged MP-214 | 28.77 ng/mL | Standard Deviation 8.024 |
| MP-214 9mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M6 (didesmethyl cariprazine) | 51.82 ng/mL | Standard Deviation 32.71 |
| MP-214 9mg | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M7 (desmethyl cariprazine) | 8.550 ng/mL | Standard Deviation 3.75 |
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MP-214 3mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 11 Participants |
| MP-214 6mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 15 Participants |
| MP-214 9mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 11 Participants |
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MP-214 3mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M7 (desmethyl cariprazine) | 4.45 hour | Standard Deviation 1.21 |
| MP-214 3mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Unchanged MP-214 | 3.31 hour | Standard Deviation 0.52 |
| MP-214 3mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M6 (didesmethyl cariprazine) | 7.76 hour | Standard Deviation 9.21 |
| MP-214 6mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M7 (desmethyl cariprazine) | 4.77 hour | Standard Deviation 2.14 |
| MP-214 6mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Unchanged MP-214 | 3.31 hour | Standard Deviation 1.02 |
| MP-214 6mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M6 (didesmethyl cariprazine) | 7.34 hour | Standard Deviation 6.83 |
| MP-214 9mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Unchanged MP-214 | 3.58 hour | Standard Deviation 0.6 |
| MP-214 9mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M6 (didesmethyl cariprazine) | 7.56 hour | Standard Deviation 7.27 |
| MP-214 9mg | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | M7 (desmethyl cariprazine) | 5.60 hour | Standard Deviation 1.22 |