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

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ClinicalTrials.gov Identifier: NCT03150771
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 14, 2017
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : May 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cohort 1
Aripiprazole; single; gluteal
Drug: Aripiprazole
Injection
Other Name: Abilify Maintena

Experimental: Cohort 2
Aripiprazole; single; gluteal
Drug: Aripiprazole
Injection
Other Name: Abilify Maintena




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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 Outcome Measures :
  1. Pharmacokinetics - Maximum plasma concentration (Cmax) [ Time Frame: Day 1 to Day 182/Early Termination ]
    The maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole

  2. Pharmacokinetics - time of maximum plasma concentration (tmax) [ Time Frame: Day 1 to Day 182/Early Termination ]
    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

  3. Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt) [ Time Frame: Day 1 to Day 182/Early Termination ]
    AUCt will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine average concentration of drug over time

  4. Pharmacokinetics - AUC calculated from time to infinity [ Time Frame: Day 1 to Day 182/Early Termination ]
    AUCinfinity will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine total drug exposure over time

  5. Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z) [ Time Frame: Day 1 to Day 182/Early Termination ]
    t1/2,z will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine drug persistence in the body



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150771


Locations
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United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
United States, California
CNRI-San Diego
San Diego, California, United States, 92102
United States, Texas
Community Clinical Research Inc.
Austin, Texas, United States, 78754
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03150771     History of Changes
Other Study ID Numbers: 031-201-00104
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aripiprazole
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists