Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001490864
Ethics application status
Approved
Date submitted
13/10/2021
Date registered
2/11/2021
Date last updated
23/03/2022
Date data sharing statement initially provided
2/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral suspension against the innovator 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral tablet conducted under fasting conditions in healthy male and female volunteers.
Scientific title
A single dose, randomized, blinded, pharmacokinetic study of a test formulation of 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral suspension in a 2 way crossover comparison against the innovator 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral tablet conducted under fasting conditions in healthy male and female volunteers.
Secondary ID [1] 305531 0
None
Universal Trial Number (UTN)
U1111-1268-3589
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine is indicated for treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics. 323921 0
Condition category
Condition code
Mental Health 321436 321436 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this trial is the test formulation of 0.25 mL of 50 mg/mL 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral suspension formulation.

Each dose is separated by a one week washout period.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose).

Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose.

Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety.

Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 24 hours after dosing.

Participants will be monitored for adverse events throughout the study.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and urine dipstick drugs of abuse testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing.

Screening and study exit laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing.

Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure that the medication has been taken as directed.
Intervention code [1] 321929 0
Treatment: Drugs
Comparator / control treatment
The comparator/control for this trial is the innovator one half (12.5mg) of 1 x 25 mg 43-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine tablet formulation.
Control group
Active

Outcomes
Primary outcome [1] 329217 0
To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine tablet using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 329217 0
0 (pre-dose) and at 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, 56 and 72 hours post dosing
Secondary outcome [1] 401803 0
Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
Timepoint [1] 401803 0
0 (pre-dose) and at 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, 56 and 72 hours post dosing

Eligibility
Key inclusion criteria
Healthy males and females
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 18.5 and less than 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Drug free as determined by urine drug testing
Able to comply with the study restrictions
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant medical conditions
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Participation in a drug study within 30 days of the start of the study
Sensitivities to the study drug or excipients
Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subject ID will be used to randomise each participant onto the study. Allocation concealment will be completed by the pharmacy staff who are independent of subject recruitment and who are unaware of the identity of each subject.

All staff obtaining consent and confirming eligibility will remain blinded as to what formulation each subject ID has been allocated. Individual randomisation envelopes will be provided in case the identity of study drug administered to a participant needs to be known.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/2021
Actual
3/12/2021
Date of last participant enrolment
Anticipated
Actual
3/12/2021
Date of last data collection
Anticipated
Actual
17/12/2021
Sample size
Target
28
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 24200 0
New Zealand
State/province [1] 24200 0
Otago

Funding & Sponsors
Funding source category [1] 309900 0
Commercial sector/Industry
Name [1] 309900 0
Douglas Pharmaceuticals Ltd
Country [1] 309900 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
PO Box 1777
156 Frederick St
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 310929 0
None
Name [1] 310929 0
Address [1] 310929 0
Country [1] 310929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309622 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 309622 0
Ethics committee country [1] 309622 0
New Zealand
Date submitted for ethics approval [1] 309622 0
13/08/2021
Approval date [1] 309622 0
27/10/2021
Ethics approval number [1] 309622 0
21/STH/222

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114806 0
Dr Noelyn Hung
Address 114806 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 114806 0
New Zealand
Phone 114806 0
+64 21 482 148
Fax 114806 0
+64 3 477 9605
Email 114806 0
[email protected]
Contact person for public queries
Name 114807 0
Linda Folland
Address 114807 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 114807 0
New Zealand
Phone 114807 0
+64 3 477 9669
Fax 114807 0
+64 3 477 9605
Email 114807 0
[email protected]
Contact person for scientific queries
Name 114808 0
Tak Hung
Address 114808 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 114808 0
New Zealand
Phone 114808 0
+64 3 477 9669
Fax 114808 0
+64 3 477 9605
Email 114808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.