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PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Aripiprazole IM Depot
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
  2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
  3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.

Exclusion Criteria:

  1. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
  2. Subjects who are alcoholomania or independent of drug, or have drug abuse history;
  3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;

Other protocol-defined inclusion and exclusion criteria may apply.

Sites / Locations

  • Beijing Anding Hospital of Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

400 mg group

Arm Description

Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally).

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax)
To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
time of maximum observed plasma concentration (tmax)
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
AUC672h
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Apparent clearance after extravascular administration
To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.

Secondary Outcome Measures

Adverse Events
Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
Vital Signs
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
Laboratory Examination
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)

Full Information

First Posted
September 11, 2017
Last Updated
July 9, 2020
Sponsor
Otsuka Beijing Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03285503
Brief Title
PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Official Title
A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
October 14, 2019 (Actual)
Study Completion Date
October 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Beijing Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
Detailed Description
To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 mg group
Arm Type
Experimental
Arm Description
Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally).
Intervention Type
Drug
Intervention Name(s)
Aripiprazole IM Depot
Other Intervention Name(s)
ABILIFY MAINTENA
Intervention Description
administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Description
To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Time Frame
up to 24 weeks
Title
time of maximum observed plasma concentration (tmax)
Description
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Time Frame
up to 24 week
Title
AUC672h
Description
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Time Frame
up to 24 weeks
Title
Apparent clearance after extravascular administration
Description
To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
Time Frame
up to 24 weeks
Title
Vital Signs
Description
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
Time Frame
up to 24 weeks
Title
Laboratory Examination
Description
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)
Time Frame
up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Positive and Negative Symptoms Scale (PANSS)
Description
To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF); Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60); subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent. Exclusion Criteria: Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR; Subjects who are alcoholomania or independent of drug, or have drug abuse history; Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing; Other protocol-defined inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Jiang, Master
Organizational Affiliation
Beijing Anding Hospital of Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

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