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Trial registered on ANZCTR


Registration number
ACTRN12621000887875
Ethics application status
Approved
Date submitted
23/06/2021
Date registered
8/07/2021
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
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 fed conditions in healthy male and female volunteers.
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 fed conditions in healthy male and female volunteers.
Secondary ID [1] 304424 0
None
Universal Trial Number (UTN)
U1111-1265-3601
Trial acronym
Linked study record

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. 322231 0
Condition category
Condition code
Neurological 319923 319923 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
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 a standardised high fat content meal 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.
Intervention code [1] 320779 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 327794 0
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.
Timepoint [1] 327794 0
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
Secondary outcome [1] 396615 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] 396615 0
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

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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

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)
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.
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)
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23756 0
New Zealand
State/province [1] 23756 0
Otago

Funding & Sponsors
Funding source category [1] 308789 0
Commercial sector/Industry
Name [1] 308789 0
Southern XP IP Pty Ltd
Address [1] 308789 0
Unit 5, 118 Church Street
Hawthorn
Vic, 3122
Country [1] 308789 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
North Dunedin
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 309698 0
None
Name [1] 309698 0
Address [1] 309698 0
Country [1] 309698 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308701 0
Northern A Health & Disability Ethics Committee
Ethics committee address [1] 308701 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 308701 0
New Zealand
Date submitted for ethics approval [1] 308701 0
26/02/2021
Approval date [1] 308701 0
06/04/2021
Ethics approval number [1] 308701 0
21/NTA/38

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to 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 fed conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111610 0
Dr Noelyn Hung
Address 111610 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 111610 0
New Zealand
Phone 111610 0
+64 21 482 148
Fax 111610 0
+64 3 477 9605
Email 111610 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 111611 0
Mrs Linda Folland
Address 111611 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 111611 0
New Zealand
Phone 111611 0
+64 3 477 9669
Fax 111611 0
+64 3 477 9605
Email 111611 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 111612 0
Dr Tak Hung
Address 111612 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 111612 0
New Zealand
Phone 111612 0
+64 3 477 9669
Fax 111612 0
+64 3 477 9605
Email 111612 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. All participant data will be provided in summary format and result of the study only will be reported
What supporting documents are/will be available?
No other documents available
Summary results
No Results