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Trial registered on ANZCTR
Registration number
ACTRN12621000775819
Ethics application status
Approved
Date submitted
26/05/2021
Date registered
21/06/2021
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of Dimethyl (2E)-but-2-enedioate capsule against the innovator Dimethyl (2E)-but-2-enedioate capsule conducted under fasting condition in healthy male and female volunteers.
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Scientific title
A single dose, randomized, blinded, two-treatment, three period, three-sequence, partial replicate, reference scaled crossover study comparing a test formulation of Dimethyl (2E)-but-2-enedioate capsule in a 3 way crossover comparison against the innovator Dimethyl (2E)-but-2-enedioate capsule conducted under fasting conditions in healthy male and female volunteers.
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Secondary ID [1]
304266
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None
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Universal Trial Number (UTN)
U1111-1265-3300
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dimethyl (2E)-but-2-enedioate is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.
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Condition category
Condition code
Neurological
319709
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Multiple sclerosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single dose, 3 period, partial replicate, reference scaled, crossover study design whereby each participant receives the test formulation of 240 mg Dimethyl (2E)-but-2-enedioate capsule on one occasion and the innovator formulation of 240 mg Dimethyl (2E)-but-2-enedioate capsule on two occasions with each dose separated by a one week washout period. The intervention for this trial is the test capsule formulation.
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 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose.
Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours 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.
Each dose ( 1 x 240 mg) 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 the medication has been taken as directed.
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Intervention code [1]
320605
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Treatment: Drugs
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Comparator / control treatment
Single dose, 3 period, partial replicate, reference scaled, crossover study whereby each participant receives the test formulation (1 x 240 mg) on one occasion and the innovator formulation of Dimethyl (2E)-but-2-enedioate (1 x 240 mg) on two occasions with each dose separated by a one week washout period. The comparator/control for this trial is the innovator capsule formulation.
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Control group
Active
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Outcomes
Primary outcome [1]
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To compare the bioequivalence of (E)-4-methoxy-4-oxobut-2-enoic-acid (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for (E)-4-methoxy-4-oxobut-2-enoic-acid using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
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Assessment method [1]
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Timepoint [1]
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Prior to dosing and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12 and 14 hours post dosing
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Prior to dosing and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12 and 14 hours post dosing
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Eligibility
Key inclusion criteria
Healthy males and non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 32
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Concomitant drug therapy of any kind
Any clinically significant medical conditions
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All formulations will be labelled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be given a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study. Sequence generation will be by using a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Bio-equivalence
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/07/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
39
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Southern XP IP Pty Ltd
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Address [1]
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Unit 5, 118 Church Street
Hawthorn
Vic, 3122
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Zenith Technology Corporation Limited
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Address
156 Frederick Street
North Dunedin
Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern A Health & Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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26/02/2021
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Approval date [1]
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06/04/2021
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Ethics approval number [1]
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21/NTA/37
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Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to the that of a reference formulation, following oral administration of a single dose of 240 mg Dimethyl (2E)-but-2-enedioate capsule to healthy male and female subjects under fasting conditions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Noelyn Hung
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Address
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Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
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Country
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New Zealand
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Phone
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+64 21 482 148
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Fax
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+64 3 477 9605
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Linda Folland
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Address
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Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
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Country
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New Zealand
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Phone
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+64 3 477 9669
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Fax
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+64 3 477 9605
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Tak Hung
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Address
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Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
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Country
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New Zealand
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Phone
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+64 3 477 9669
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Fax
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+64 3 477 9605
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported
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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.
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