PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

• ClinicalTrials.gov Identifier: NCT03285503
• Recruitment Status: Completed
• First Posted: September 18, 2017
• Last Update Posted: July 10, 2020
• Sponsor: Otsuka Beijing Research Institute
• Information provided by (Responsible Party): Otsuka Beijing Research Institute

Tracking Information

• First Submitted Date: September 11, 2017
• First Posted Date: September 18, 2017
• Last Update Posted Date: July 10, 2020
• Actual Study Start Date: August 17, 2018
• Actual Primary Completion Date: October 14, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 14, 2017)

• Maximum Plasma Concentration (Cmax) [ Time Frame: up to 24 weeks ]
  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) [ Time Frame: up to 24 week ]
  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 [ Time Frame: up to 24 weeks ]
  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 [ Time Frame: up to 24 weeks ]
  To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 14, 2017)

• Adverse Events [ Time Frame: up to 24 weeks ]
  Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
• Vital Signs [ Time Frame: up to 24 weeks ]
  Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
• Laboratory Examination [ Time Frame: up to 24 weeks ]
  Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 14, 2017)

Positive and Negative Symptoms Scale (PANSS) [ Time Frame: up to 24 weeks ]

To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Schizophrenia

Intervention

Drug: Aripiprazole IM Depot

administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.

Other Name: ABILIFY MAINTENA

Study Arms

Experimental: 400 mg group

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: Drug: Aripiprazole IM Depot

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2017): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 14, 2019
• Actual Primary Completion Date: October 14, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03285503
• Other Study ID Numbers: 031-403-00049
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Otsuka Beijing Research Institute
• Study Sponsor: Otsuka Beijing Research Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tao Jiang, Master; Beijing Anding Hospital of Capital Medical University

• PRS Account: Otsuka Beijing Research Institute
• Verification Date: January 2020