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

NCT03150771 | Completed Phase 1 FDA Drug

• 1 other identifier: 031-201-00104
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (8)

• Incidence of Adverse Events (AEs) [safety and tolerability]

  AEs will be monitored to assess safety and tolerability of drug

  Screening Days -30 to Day 182 post dose/Early Termination

• Clinical Laboratory Tests [safety and tolerability]

  Hematology, clinical chemistry \& urinalysis tests will be performed to assess the safety and tolerability of drug.

  Screening Days -30 to Day 182 post dose/Early Termination

• Electrocardiograms (ECGs) [Safety and tolerability]

  Heart rate, RR, PR, WRS and WT intervals will be monitored to assess the safety and tolerability of the drug.

  Screening Days -30 to Day 182 post dose/Early Termination

• Vital Signs [safety and tolerability]

  Systolic/diastolic blood pressure, heart rate and body temperature will be monitored to assess the safety and tolerability of the drug.

  Screening Days -30 to Day 182 post dose/Early Termination

• Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability]

  C-SSRS score will be monitored throughout the trial to assess the safety and tolerability of drug

  Screening Days -30 to Day 182 post dose/Early Termination

• Extrapyramidal Symptoms (EPS) Rating Scales

  EPS score will be monitored to assess safety and tolerability of drug

  Screening Days -30 to Day 182 post dose/Early Termination

• Investigator's Assessment of Injection Site

  The injection site will be monitored to assess the safety and tolerability of drug

  Screening Days -30 to Day 182 post dose/Early Termination

• Visual Analog Scale (VAS) Scores for Pain Perception

  VAS score will be monitored to assess safety and tolerability of drug

  Day 1 to Day 28 post dose

Secondary Outcomes (5)

• Pharmacokinetics - Maximum plasma concentration (Cmax)

  Day 1 to Day 182/Early Termination

• Pharmacokinetics - time of maximum plasma concentration (tmax)

  Day 1 to Day 182/Early Termination

• Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt)

  Day 1 to Day 182/Early Termination

• Pharmacokinetics - AUC calculated from time to infinity

  Day 1 to Day 182/Early Termination

• Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)

  Day 1 to Day 182/Early Termination

Study Arms (2)

Cohort 1

EXPERIMENTAL

Aripiprazole; single; gluteal

Drug: Aripiprazole

Cohort 2

EXPERIMENTAL

Aripiprazole; single; gluteal

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Injection

Also known as: Abilify Maintena

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• H. Lundbeck A/S: collaborator

Study Sites (3)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

CNRI-San Diego

San Diego, California, 92102, United States

Location

Community Clinical Research Inc.

Austin, Texas, 78754, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 12, 2017
• Study Start: June 14, 2017
• Primary Completion: April 18, 2018
• Study Completion: May 2, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

US (3)