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

NCT02220712 | Completed Phase 1 Results

• 2 other identifiers: 031-13-005JapicCTI-142635
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 5

Brief Summary

To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Conditions

Schizophrenia

Keywords

Aripiprazole; Deltoid

Outcome Measures

Primary Outcomes (1)

• OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections

  672 hours postdose of the first, second, third, fourth, and fifth IMD injections

Study Arms (1)

Drug: OPC-14597 IMD

EXPERIMENTAL

Drug: OPC-14597 IMD

Interventions

OPC-14597 IMD DRUG

Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Drug: OPC-14597 IMD

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60)
• Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.)
• Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent
• Patients with a body mass index of 18.5 or higher and lower than 35.0
• Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent
• Patients who have received aripiprazole in the past

You may not qualify if:

• Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria.
• Patients with a history or complication of diabetes.
• Patients with hepatic, renal, cardiac, or hematopoietic disorders.
• Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant.
• Patients who have a drug allergy or drug hypersensitivity
• Patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine.
• Patients with a complication of Parkinson's Disease (excluding drug-induced Parkinsonism).
• Patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication.
• Patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc).
• Patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent.
• Patients with a history of or a complication of convulsive disorder such as epilepsy.
• Patients with a history of or a complication of organic brain disorder including cerebrovascular disease.
• Patients with a history or a complication of granulocytopenia or agranulocytosis.
• Patients who have received electro-convulsive therapy (ECT) within 12 weeks prior to obtaining informed consent.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Jun-ichi Hashimoto, PhD

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Locations

JP (5)