Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000109707
Ethics application status
Approved
Date submitted
11/01/2022
Date registered
24/01/2022
Date last updated
16/03/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers.
Scientific title
A multiple dose, randomized, blinded, pharmacokinetic study of a generic formulation of 2 mg N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fasting conditions and at steady state in healthy volunteers.
Secondary ID [1] 306168 0
None
Universal Trial Number (UTN)
U1111-1271-8452
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. 324877 0
Condition category
Condition code
Mental Health 322313 322313 0 0
Other mental health disorders
Neurological 322417 322417 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple dose, crossover study design whereby each participant receives the test formulation of 2 mg N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet on five occasions and the innovator formulation of 2 mg N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet on five occasions with each dosing period. There will be a minimum of 10 days between each dosing period. The intervention for this trial is the test tablet formulation.

On study days 1-5 participants will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses of the other formulation (either the innovator or test).

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

Participants are required not to eat for 4 hours before receiving each dose on study days 1 to 4 and 15 to 18.

On study days 5 and 19 subjects will report to the Zenith Clinical Site for dosing and observation of adverse events and the provision of one blood sample. They are required to stay at the clinical site for 24 hours after dosing.

On study days 1 to 4 and 15 to 18 subjects will report to Zenith Technology for dosing and the provision of one blood sample.

On study day 5 and 19 no water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose) and subjects are required to fast for 8 hours prior to receiving the dose and approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 8 hours prior to dosing to ensure compliance can be monitored and for 24 hours after dosing.

Standard meals will be consumed at the Clinical Site on study days 5 and 19 with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site prior to dosing.

Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing.
Intervention code [1] 322575 0
Treatment: Drugs
Comparator / control treatment
The comparator/control for this trial is the innovator 1 x 2 mg N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet
Control group
Active

Outcomes
Primary outcome [1] 330075 0
To compare the bioavailability of N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 330075 0
Pre-dose on days 1-4 and 15-18 then on study days 5 and 19 at -1, -0.5, 0 (pre-dose) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16, 18, 20 and 24 hours post dosing.
Secondary outcome [1] 404809 0
Time to maximum peak concentration (Tmax). Tmax will be the time where the maximum concentration occurred in the sample points. All plasma samples will be assayed for N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide using a fully validated LC/MS/MS method.
Timepoint [1] 404809 0
Pre-dose on days 1-4 and 15-18 then on study days 5 and 19 at -1, -0.5, 0 (pre-dose) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16, 18, 20 and 24 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 and less than 33 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 24489 0
New Zealand
State/province [1] 24489 0
Otago

Funding & Sponsors
Funding source category [1] 310513 0
Commercial sector/Industry
Name [1] 310513 0
Neo Health (OTC) Pty Ltd, Australia
Country [1] 310513 0
Australia
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] 311679 0
None
Name [1] 311679 0
Address [1] 311679 0
Country [1] 311679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310138 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310138 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 310138 0
New Zealand
Date submitted for ethics approval [1] 310138 0
18/11/2021
Approval date [1] 310138 0
10/03/2022
Ethics approval number [1] 310138 0
2021 FULL 11779

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to that of the reference formulations, following oral administration of a N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet. In this study we will measure how much N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is absorbed into the bloodstream and compare the concentrations between the test and reference formulations at steady state and in fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116610 0
Dr Noelyn Hung
Address 116610 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 116610 0
New Zealand
Phone 116610 0
+64 21 482 148
Fax 116610 0
Email 116610 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 116611 0
Mrs Linda Folland
Address 116611 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 116611 0
New Zealand
Phone 116611 0
+64 3 477 9669
Fax 116611 0
Email 116611 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 116612 0
Dr Tak Hung
Address 116612 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 116612 0
New Zealand
Phone 116612 0
+64 3 477 9669
Fax 116612 0
Email 116612 0
tak.hung@zenithtechnology.co.nz

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.