Trial Outcomes & Findings for A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (NCT NCT01626859)
NCT ID: NCT01626859
Last Updated: 2026-01-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
38 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
16
|
11
|
|
Overall Study
COMPLETED
|
9
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
2
|
Baseline Characteristics
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
MP-214 3mg
n=11 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
MP-214 6mg
n=16 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
MP-214 9mg
n=11 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13.2 • n=9667 Participants
|
43.1 years
STANDARD_DEVIATION 10.7 • n=6597 Participants
|
43.2 years
STANDARD_DEVIATION 13.3 • n=16264 Participants
|
43.1 years
STANDARD_DEVIATION 11.9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9667 Participants
|
9 Participants
n=6597 Participants
|
6 Participants
n=16264 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9667 Participants
|
7 Participants
n=6597 Participants
|
5 Participants
n=16264 Participants
|
18 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksOutcome measures
| Measure |
MP-214 3mg
n=11 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
MP-214 6mg
n=16 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
MP-214 9mg
n=11 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
11 Participants
|
15 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.Outcome measures
| Measure |
MP-214 3mg
n=11 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
MP-214 6mg
n=16 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
MP-214 9mg
n=11 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
|---|---|---|---|
|
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
|
5.963 ng/mL
Standard Deviation 1.593
|
8.550 ng/mL
Standard Deviation 3.750
|
|
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
|
35.94 ng/mL
Standard Deviation 7.995
|
51.82 ng/mL
Standard Deviation 32.71
|
|
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
|
22.65 ng/mL
Standard Deviation 4.181
|
28.77 ng/mL
Standard Deviation 8.024
|
PRIMARY outcome
Timeframe: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.Outcome measures
| Measure |
MP-214 3mg
n=11 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
MP-214 6mg
n=16 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
MP-214 9mg
n=11 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
|---|---|---|---|
|
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
|
4.77 hour
Standard Deviation 2.14
|
5.60 hour
Standard Deviation 1.22
|
|
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
|
7.34 hour
Standard Deviation 6.83
|
7.56 hour
Standard Deviation 7.27
|
|
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
|
3.31 hour
Standard Deviation 1.02
|
3.58 hour
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.Outcome measures
| Measure |
MP-214 3mg
n=11 Participants
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
MP-214 6mg
n=16 Participants
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
MP-214 9mg
n=11 Participants
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
|---|---|---|---|
|
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
|
358.37 ng*h/mL
Standard Deviation 85.24
|
466.36 ng*h/mL
Standard Deviation 154.55
|
|
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
|
115.26 ng*h/mL
Standard Deviation 23.47
|
163.31 ng*h/mL
Standard Deviation 72.72
|
|
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
|
800.21 ng*h/mL
Standard Deviation 206.73
|
1140.42 ng*h/mL
Standard Deviation 711.59
|
Adverse Events
MP-214 3mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
MP-214 6mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
MP-214 9mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-214 3mg
n=11 participants at risk
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
MP-214 6mg
n=16 participants at risk
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
MP-214 9mg
n=11 participants at risk
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/11
|
12.5%
2/16
|
0.00%
0/11
|
Other adverse events
| Measure |
MP-214 3mg
n=11 participants at risk
MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
MP-214 6mg
n=16 participants at risk
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
MP-214 9mg
n=11 participants at risk
MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Endocrine disorders
Hyperprolactinaemia
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Eye disorders
Cataract
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11
|
12.5%
2/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Dental caries
|
9.1%
1/11
|
6.2%
1/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Gastritis
|
18.2%
2/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Haematochezia
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11
|
12.5%
2/16
|
18.2%
2/11
|
|
General disorders
Chest discomfort
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
General disorders
Chills
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
General disorders
Feeling abnormal
|
9.1%
1/11
|
0.00%
0/16
|
9.1%
1/11
|
|
General disorders
Irritability
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
General disorders
Malaise
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
General disorders
Pyrexia
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Immune system disorders
Seasonal allergy
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11
|
18.8%
3/16
|
9.1%
1/11
|
|
Infections and infestations
Hordeolum
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Infections and infestations
Nasopharyngitis
|
27.3%
3/11
|
37.5%
6/16
|
9.1%
1/11
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Infections and infestations
Tinea infection
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Excoriation
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Thermal burn
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11
|
12.5%
2/16
|
0.00%
0/11
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11
|
12.5%
2/16
|
0.00%
0/11
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Investigations
Blood creatine phosphokinase increased
|
9.1%
1/11
|
12.5%
2/16
|
0.00%
0/11
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Investigations
Blood prolactin increased
|
9.1%
1/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Investigations
Blood uric acid increased
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Investigations
Blood urine present
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Investigations
Heart rate increased
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Investigations
Liver function test abnormal
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Investigations
Red blood cell count increased
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Investigations
Thyroxine free increased
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Investigations
Weight decreased
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Investigations
White blood cell count increased
|
9.1%
1/11
|
12.5%
2/16
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Electrolyte depletion
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11
|
6.2%
1/16
|
9.1%
1/11
|
|
Nervous system disorders
Akathisia
|
45.5%
5/11
|
18.8%
3/16
|
27.3%
3/11
|
|
Nervous system disorders
Athetosis
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Nervous system disorders
Dizziness postural
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Nervous system disorders
Dyskinesia
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Nervous system disorders
Headache
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Nervous system disorders
Sedation
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11
|
18.8%
3/16
|
9.1%
1/11
|
|
Nervous system disorders
Tremor
|
0.00%
0/11
|
18.8%
3/16
|
0.00%
0/11
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11
|
25.0%
4/16
|
27.3%
3/11
|
|
Psychiatric disorders
Restlessness
|
54.5%
6/11
|
25.0%
4/16
|
18.2%
2/11
|
|
Psychiatric disorders
Schizophrenia
|
9.1%
1/11
|
31.2%
5/16
|
9.1%
1/11
|
|
Psychiatric disorders
Suicidal ideation
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
9.1%
1/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
9.1%
1/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/11
|
0.00%
0/16
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Vascular disorders
Hot flush
|
0.00%
0/11
|
6.2%
1/16
|
0.00%
0/11
|
|
Vascular disorders
Hypertension
|
9.1%
1/11
|
0.00%
0/16
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER