PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole IM Depot

• Registration Number: NCT03285503
• Lead Sponsor: Otsuka Beijing Research Institute

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 Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Study Start: 2018-08-17
• Primary Completion: 2019-10-14
• Study Completion: 2019-10-14
• Status Verified: 2020-01
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
400 mg group	Aripiprazole IM Depot	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).

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	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.
AUC672h	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	up to 24 weeks	To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.
time of maximum observed plasma concentration (tmax)	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	up to 24 weeks	Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
Vital Signs	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	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)

Trial Locations

Locations (1)

Beijing Anding Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China