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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

About this trial

This is an interventional supportive care trial for Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Woodland International Research Group
CNRI-San Diego
Community Clinical Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Aripiprazole; single; gluteal

Outcomes

Primary Outcome Measures

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

AEs will be monitored to assess safety and tolerability of drug

Clinical Laboratory Tests [safety and tolerability]

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

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.

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.

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

Extrapyramidal Symptoms (EPS) Rating Scales

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

Investigator's Assessment of Injection Site

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

Visual Analog Scale (VAS) Scores for Pain Perception

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

Secondary Outcome Measures

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

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

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

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

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

Full Information

NCT ID

NCT03150771

First Posted

May 2, 2017

Last Updated

June 11, 2018

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT03150771

Brief Title

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

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

June 14, 2017 (Actual)

Primary Completion Date

April 18, 2018 (Actual)

Study Completion Date

May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Aripiprazole; single; gluteal

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Aripiprazole; single; gluteal

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify Maintena

Intervention Description

Injection

Primary Outcome Measure Information:

Title

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

Description

AEs will be monitored to assess safety and tolerability of drug

Time Frame