Status:
COMPLETED
A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
PRA Health Sciences
H. Lundbeck A/S
Conditions:
Schizophrenia
Bipolar I Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects ...
Eligibility Criteria
Inclusion
- Male and female subjects between 18 and 64 years of age, inclusive.
- Body mass index of 18 to 35 kg/m2, inclusive.
- A current diagnosis of schizophrenia or a current diagnosis of bipolar I disorder as defined by DSM-5 criteria.
- Prior history of tolerating aripiprazole per investigator's judgment.
Exclusion
- Subjects who have met DSM-5 criteria for substance dependence within the past 180 days
- Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
- Subjects may not receive varenicline beyond screening.
- Use of any prescription medication not specifically approved by the medical monitor.
- Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female subjects.
- Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole LAI trial within the last 1 year (ie, enrolled but did not receive aripiprazole LAI); or who had previously enrolled and received IMP in an aripiprazole LAI clinical trial.
- Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
- Subjects currently in an acute relapse of schizophrenia.
- Subjects with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder
- Electroconvulsive therapy must not be conducted within 2 months prior to administration of the IMP
- Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
- Subjects deemed intolerant of receiving injections.
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03854409
Start Date
January 31 2019
End Date
February 20 2020
Last Update
September 2 2020
Active Locations (4)
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1
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
2
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
3
Hassman Research Institute
Berlin, New Jersey, United States, 08009
4
Community Clinical Research
Austin, Texas, United States, 78754