Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia

NCT ID: NCT03150771

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2018-05-02

Brief Summary

This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cohort 1

Aripiprazole; single; gluteal

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection

Cohort 2

Aripiprazole; single; gluteal

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection

Interventions

Aripiprazole

Injection

Intervention Type: DRUG

Other Intervention Names

Abilify Maintena

Eligibility Criteria

Inclusion Criteria

• Male and female individuals between 18 and 64 years, inclusive, at screening with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders: edition 5 (DSM-5)
• Body mass index (BMI) between 18 and 35 kg/m^2 at screening
• Male and female subjects who are surgically sterile, female subjects who have been postmenopausal for at least 12 consecutive months prior to screening or male/female subjects who agree to remain abstinent or practice 2 of the approved birth control methods from screening for at least 150 days after dose of Investigational Medical Product (IMP) for female subjects or 180 days after dose of IMP for male subjects.
• Documented history of previously tolerating Aripiprazole per investigator's judgment.

Exclusion Criteria

• Met DSM-5 criteria for substance use disorder within past 180 days
• Positive drug screen for drugs of abuse
• Use of more than 1 antipsychotic medication at screening or baseline, except for oral Aripiprazole administered during tolerability testing and current antipsychotic medication
• Subjects may not receive varenicline beyond the screening visit.
• Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to administration of IMP
• Major surgery within 30 days prior to administration of IMP or surgery during the trial
• Subjects at significant risk of committing suicide based on history, psychiatric exams
• Subjects currently in an acute relapse of schizophrenia
• Subjects with a current DSM-5 diagnosis other than schizophrenia
• Subjects with a history of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia
• Subjects who have had electroconvulsive therapy within 2 months prior to administration of IMP
• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP
• History of or current hepatitis or Acquired Immunodeficiency Syndrome or carriers of Hepatitis B surface antigen (HBsAG), Hepatitis C antigen (anti-HCV) and/or Human Immunodeficiency Virus (HIV) antibodies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woodland International Research Group

Little Rock, Arkansas, United States

CNRI-San Diego

San Diego, California, United States

Community Clinical Research Inc.

Austin, Texas, United States

Countries

United States

Other Identifiers

031-201-00104

Identifier Type: -

Identifier Source: org_study_id