Trial Outcomes & Findings for A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia (NCT NCT02220712)
NCT ID: NCT02220712
Last Updated: 2021-01-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
672 hours postdose of the first, second, third, fourth, and fifth IMD injections
Results posted on
2021-01-25
Participant Flow
Participant milestones
| Measure |
OPC-14597 IMD
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
OPC-14597 IMD
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Exacerbation of symptoms of an underlying disease
|
1
|
Baseline Characteristics
A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
OPC-14597 IMD
n=17 Participants
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 672 hours postdose of the first, second, third, fourth, and fifth IMD injectionsPopulation: Pharmacokinetic analysis set included subjects whose plasma concentrations were measured without deviation at all blood sampling timepoints during the OPC-14597 IMD treatment period.
Outcome measures
| Measure |
OPC-14597 IMD (First Dose)
n=13 Participants
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
OPC-14597 IMD (Second Dose)
n=13 Participants
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
OPC-14597 IMD (Third Dose)
n=13 Participants
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
OPC-14597 IMD (Fourth Dose)
n=13 Participants
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
OPC-14597 IMD (Fifth
n=13 Participants
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
|---|---|---|---|---|---|
|
OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
|
91.9 ng/mL
Standard Deviation 29.4
|
141 ng/mL
Standard Deviation 54.0
|
171 ng/mL
Standard Deviation 76.1
|
198 ng/mL
Standard Deviation 102
|
201 ng/mL
Standard Deviation 88.9
|
Adverse Events
OPC-14597 IMD
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-14597 IMD
n=17 participants at risk
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
|---|---|
|
Psychiatric disorders
Schizophrenia
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
Other adverse events
| Measure |
OPC-14597 IMD
n=17 participants at risk
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
29.4%
5/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Infections and infestations
Pharyngitis
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Psychiatric disorders
Schizophrenia
|
11.8%
2/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Nervous system disorders
Dyskinesia
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
11.8%
2/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
General disorders
Injection site pain
|
35.3%
6/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Gastrointestinal disorders
Injection site induration
|
11.8%
2/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
General disorders
Injection site swelling
|
11.8%
2/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
General disorders
Injection site erythema
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
General disorders
Injection site discomfort
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Investigations
Weight increased
|
17.6%
3/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Investigations
Blood glucose increased
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Investigations
Blood insulin increased
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Investigations
Glucose urine present
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Investigations
Glycosylated haemoglobin increased
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.9%
1/17 • 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place