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

Otsuka

Status and phase

Completed

Phase 1

Conditions

Schizophrenia

Treatments

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT03150771

031-201-00104

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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