Clinical trial NCT03150771: Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2017-05-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Incidence of Adverse Events (AEs) [safety and tolerability]
timeFrame: Screening Days -30 to Day 182 post dose/Early Termination
measure: Clinical Laboratory Tests [safety and tolerability]
timeFrame: Screening Days -30 to Day 182 post dose/Early Termination
measure: Electrocardiograms (ECGs) [Safety and tolerability]
timeFrame: Screening Days -30 to Day 182 post dose/Early Termination
measure: Vital Signs [safety and tolerability]
timeFrame: Screening Days -30 to Day 182 post dose/Early Termination
measure: Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability]
timeFrame: Screening Days -30 to Day 182 post dose/Early Termination
measure: Extrapyramidal Symptoms (EPS) Rating Scales
timeFrame: Screening Days -30 to Day 182 post dose/Early Termination
measure: Investigator's Assessment of Injection Site
timeFrame: Screening Days -30 to Day 182 post dose/Early Termination
measure: Visual Analog Scale (VAS) Scores for Pain Perception
timeFrame: Day 1 to Day 28 post dose
Secondary outcomes:
measure: Pharmacokinetics - Maximum plasma concentration (Cmax)
timeFrame: Day 1 to Day 182/Early Termination
measure: Pharmacokinetics - time of maximum plasma concentration (tmax)
timeFrame: Day 1 to Day 182/Early Termination
measure: Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt)
timeFrame: Day 1 to Day 182/Early Termination
measure: Pharmacokinetics - AUC calculated from time to infinity
timeFrame: Day 1 to Day 182/Early Termination
measure: Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)
timeFrame: Day 1 to Day 182/Early Termination
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: San Diego
country: United States
facility: CNRI-San Diego
state: California
city: Austin
country: United States
facility: Community Clinical Research Inc.
state: Texas
Study officials:
References: