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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150771
• Other study ID #: 031-201-00104
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: June 2018
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole
Injection

Locations

Country	Name	City	State
United States	Community Clinical Research Inc.	Austin	Texas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	CNRI-San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pharmacokinetics - Maximum plasma concentration (Cmax)	The maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole	Day 1 to Day 182/Early Termination
Secondary	Pharmacokinetics - time of maximum plasma concentration (tmax)	The amount of time that the maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole	Day 1 to Day 182/Early Termination
Secondary	Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt)	AUCt will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine average concentration of drug over time	Day 1 to Day 182/Early Termination
Secondary	Pharmacokinetics - AUC calculated from time to infinity	AUCinfinity will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine total drug exposure over time	Day 1 to Day 182/Early Termination
Secondary	Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)	t1/2,z will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine drug persistence in the body	Day 1 to Day 182/Early Termination