A Phase 1, Open-label, Single Ascending Dose, Parallel Arm Trial to Determine the Pharmacokinetics, Safety, and Tolerability of Aripiprazole 2 Month Intramuscular Depot Administered Gluteally in Adult Subjects With Schizophrenia
Overview
- Phase
- Phase 1
- Intervention
- Aripiprazole
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 36
- Locations
- 3
- Primary Endpoint
- Electrocardiograms (ECGs) [Safety and tolerability]
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
Investigators
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
Arms & Interventions
Cohort 1
Aripiprazole; single; gluteal
Intervention: Aripiprazole
Cohort 2
Aripiprazole; single; gluteal
Intervention: Aripiprazole
Outcomes
Primary Outcomes
Electrocardiograms (ECGs) [Safety and tolerability]
Time Frame: Screening Days -30 to Day 182 post dose/Early Termination
Heart rate, RR, PR, WRS and WT intervals will be monitored to assess the safety and tolerability of the drug.
Vital Signs [safety and tolerability]
Time Frame: Screening Days -30 to Day 182 post dose/Early Termination
Systolic/diastolic blood pressure, heart rate and body temperature will be monitored to assess the safety and tolerability of the drug.
Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability]
Time Frame: Screening Days -30 to Day 182 post dose/Early Termination
C-SSRS score will be monitored throughout the trial to assess the safety and tolerability of drug
Clinical Laboratory Tests [safety and tolerability]
Time Frame: Screening Days -30 to Day 182 post dose/Early Termination
Hematology, clinical chemistry \& urinalysis tests will be performed to assess the safety and tolerability of drug.
Incidence of Adverse Events (AEs) [safety and tolerability]
Time Frame: Screening Days -30 to Day 182 post dose/Early Termination
AEs will be monitored to assess safety and tolerability of drug
Extrapyramidal Symptoms (EPS) Rating Scales
Time Frame: Screening Days -30 to Day 182 post dose/Early Termination
EPS score will be monitored to assess safety and tolerability of drug
Investigator's Assessment of Injection Site
Time Frame: Screening Days -30 to Day 182 post dose/Early Termination
The injection site will be monitored to assess the safety and tolerability of drug
Visual Analog Scale (VAS) Scores for Pain Perception
Time Frame: Day 1 to Day 28 post dose
VAS score will be monitored to assess safety and tolerability of drug
Secondary Outcomes
- Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)(Day 1 to Day 182/Early Termination)
- 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)