Compare and evaluate the bioavailability of Aripiprazole Extended-Release Injectable Suspension (HBT009; Test) and ABILIFY MAINTENA® (Aripiprazole Extended-Release Injectable Suspension) of Otsuka Pharmaceutical Co., Ltd., in Adult Subjects with Schizophrenia and/or Schizoaffective Disorder.
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2021/08/035402
- Lead Sponsor
- HBT Labs Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or female ages 18 through 65 years, both inclusive.
2) Subject diagnosed with schizophrenia and/or schizoaffective disorder
as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition (DSM-5) criteria for at least 1 year and clinically stable for the
past 4 months (non-acute) in the investigatorâ??s judgement and in the
judgement of the treating psychiatrist if the subject is not an on-going
subject of the investigator and based on the following objective criteria
at the time of screening visit (Visit 1):
Outpatient status during the entire 4-month period preceding the
screening visit (Visit 1)
ï??ï? Score of <= 4 on the following Positive and Negative Syndrome Scale
(PANSS) items
•ï? Conceptual disorganization
•ï? Hallucinatory behavior
•Suspiciousness / persecution
•Hostility
•Unusual thought content
A total score on the 5 PANSS items <= 18
3) Subjects who have received documented treatment with at least three
consecutive monthly intramuscular injection doses of ABILIFY
MAINTENA® 400 mg into the deltoid or gluteal muscle in the 3 months
immediately prior to the screening visit (up to Day - 21). Subject who
received prior gluteal injections will receive one additional injection
into the deltoid muscle.
4) Subject is on stable regimen of oral Aripiprazole 10-20 mg prior to
screening, if not already on a stable monthly regimen of 400 mg of
Aripiprazole Extended-Release Injectable Suspension. Such subject
will receive at least three consecutive doses of 400 mg ABILIFY
MAINTENA® every 28 days into the deltoid muscle before
randomization.
5) Body mass index (BMI) >= 18 kg/m2 at screening visit (Visit 1).
PROTOCOL # HBT009
Protocol Version No.: 02
Date: 17 Mar 2021
Confidential Page 15 of 124
6) Eligible female subject will be:
Non-pregnant, evidenced by serum HCG tests at screening.
Non-lactating.
Surgically sterile or postmenopausal, defined as at least 1 year of
spontaneous amenorrhea prior to screening visit (Visit 1), or agree to
continue to use an accepted method of birth control during the entire
study and for at least 4 months after the last injection received in the
study.
Acceptable methods of birth control are: hormonal contraceptives;
double barrier method; intrauterine device; surgical sterility for at least
6 months prior to screening visit (Visit 1) by tubal ligation; surgical
sterility for at least 6 months prior to screening by hysterectomy and/or
bilateral oophorectomy; and/or postmenopausal status (defined as at
least 1 year without menses. Intended abstinence is not considered an
acceptable method of birth control for this study; subject must agree to
use an acceptable method of birth control while they become sexually
active during the study or within 4 months after the last dose of study
medication.
7) The subject and LAR must demonstrate adequate decision-making
ability to make an informed choice about participating in this study by
providing written informed consent. Subject must have an ability to
communicate effectively with the investigator and other study center
personnel and
Subject will not be eligible for inclusion in this study if any of the following
criteria apply:
1) Treatment with a second antipsychotic that is any formulation of
aripiprazole or a metabolite or pro-drug of aripiprazole (treatment with
a second antipsychotic other than aripiprazole, an aripiprazole
metabolite, or an aripiprazole pro-drug is not exclusionary).
2) Subject who has a concurrent primary psychiatric (by the DSM 5 criteria) diagnosis of intellectual development disorder and having dementia related psychosis.
3) Subject who has attempted suicide within 1 year prior to screening or that are at significant risk of a suicide attempt based on history or the investigators judgement as per C-SSRS scale.
4) Subject who has physically assaulted or acted substantially aggressive
toward another person or animal or caused significant property damage
due to aggressive behavior within 1 year prior to the screening visit
(Visit 1) or that are at significant risk of such behaviors based on
clinical interview.
5) History of a moderate or severe substance use disorder (including
alcohol and excluding only tobacco-related use disorders [caffeine is
not a substance that is subject to a diagnosis of substance use disorder
in DSM-5]; mild substance use disorder is not exclusionary if in the
opinion of the investigator the mild substance use disorder will not
interfere with the potential subjectâ??s ability to comply with protocol
requirements) by DSM-5 criteria during the 6-month period
immediately prior to screening or positive drug test at screening (Visit
1) and at randomization visit.
6) Subject is unwilling to abstain from grapefruit juice, pomelo juice,
seville orange juice, and grape juice for at least 7 days prior to
randomization visit and throughout the study prior to all clinical
research unit (CRU) visits. Subject will be instructed to keep
consumption of caffeine and caffeine-containing products consistent
(e.g., do not decrease or increase their daily intake of caffeine).
7) Subject with a history of neuroleptic malignant syndrome or tardive
dyskinesia.
8) Subject who has a concurrent primary neurological diagnosis of
idiopathic Parkinsonâ??s disease.
9) Subject who has any uncontrolled, unstable clinically relevant medical
condition (e.g., cardiovascular, respiratory, hematologic,
cerebrovascular, hepatic, renal, endocrine, immunologic or other
medical condition), which in the judgment of the investigator and
sponsor would interfere with the subjects ability to participate in the
study.
10) Clinically significant new illness in the 1 month prior to screening visit
(Visit 1) or any hospitalization for a medical or psychiatric condition
within 4 months of the screening visit (Visit 1).
11) Subject who presents with any of the signs and symptoms of COVID-
19 such as fever or chills, cough, shortness of breath, fatigue, muscle or
body aches, headache, new loss of taste or smell, sore throat, congestion
or sunny nose, nausea or vomiting, and diarrhea.
12) Subject with history of organ transplantation.
13) Malignancy within 5 years of the screening visit (Visit 1) (except for
basal cell and squamous cell skin carci
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the PK parameters that pertain to rate and extent of absorption of Aripiprazole <br/ ><br>extended-release injectable suspension (HBT009) 400 mg to ABILIFY MAINTENA® 400 <br/ ><br>mg in order to determine if these two formulations are bioequivalent (BE) after steady-state dosing <br/ ><br>Timepoint: 4 Months
- Secondary Outcome Measures
Name Time Method To compare the safety of multiple doses (four doses) of HBT009 400 mg to multiple doses <br/ ><br>(four doses) of ABILIFY MAINTENA® 400 mg. Safety assessment will be based on adverse <br/ ><br>events, vital signs, laboratory measurements (hematology, clinical chemistry, urinalysis), and <br/ ><br>electrocardiogram (ECG) results. <br/ ><br>â?¢ï? Due to the potential clinical consequences of relapse of schizophrenia, any relapse or change <br/ ><br>in clinical status will be considered a safety objective. <br/ ><br> <br/ ><br>Timepoint: 4 Months