Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000576123
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
12/04/2019
Date last updated
2/07/2021
Date data sharing statement initially provided
12/04/2019
Date results information initially provided
2/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of dimethyl fumarate capsule against the innovator dimethyl fumarate capsule conducted under fasting condition in healthy male and female volunteers.
Scientific title
A single dose, randomized, blinded, pilot study of a test formulation of dimethyl fumarate capsule in a 2 way crossover comparison against the innovator dimethyl fumarate capsule conducted under fasting conditions in healthy male and female volunteers.
Secondary ID [1] 297922 0
None
Universal Trial Number (UTN)
U1111-1299-5649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dimethyl fumarate is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability. 312308 0
Condition category
Condition code
Neurological 310870 310870 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 240 mg dimethyl fumarate capsule on one occasion and the innovator formulation of 240 mg dimethyl fumarate capsule on one occasion 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 204 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] 314137 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation (1 x 240 mg) on one occasion and the innovator formulation of dimethyl fumarate (1 x 240 mg) on one occasion 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] 319693 0
To compare the bioavailability of monomethyl difumarate (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for monomethyl fumarate using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 319693 0
0, 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] 369194 0
The 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] 369194 0
0, 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
Sex
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 - Trails 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
Completed
Date of first participant enrolment
Anticipated
27/04/2019
Actual
3/05/2019
Date of last participant enrolment
Anticipated
Actual
13/05/2019
Date of last data collection
Anticipated
Actual
13/05/2019
Sample size
Target
12
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 21394 0
New Zealand
State/province [1] 21394 0
Otago

Funding & Sponsors
Funding source category [1] 302438 0
Commercial sector/Industry
Name [1] 302438 0
Southern Cross Pharma Pty Ltd
Country [1] 302438 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 302340 0
None
Name [1] 302340 0
Address [1] 302340 0
Country [1] 302340 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303107 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 303107 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 303107 0
New Zealand
Date submitted for ethics approval [1] 303107 0
07/03/2019
Approval date [1] 303107 0
04/04/2019
Ethics approval number [1] 303107 0
19/NTA/45

Summary
Brief summary
The objective of this pilot study is to evaluate the bioequivalence of the test formulation relative to the that of a reference formulation, following oral administration of a combination single dose of 240 mg dimethyl fumarate capsule to healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92498 0
Dr Noelyn Hung
Address 92498 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 92498 0
New Zealand
Phone 92498 0
+64 3 477 9669
Fax 92498 0
+6434779605
Email 92498 0
[email protected]
Contact person for public queries
Name 92499 0
Mrs Linda Folland
Address 92499 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 92499 0
New Zealand
Phone 92499 0
+64 3 477 9669
Fax 92499 0
+6434779605
Email 92499 0
[email protected]
Contact person for scientific queries
Name 92500 0
Dr Tak Hung
Address 92500 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 92500 0
New Zealand
Phone 92500 0
+64 3 477 9669
Fax 92500 0
+6434779605
Email 92500 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. 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 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.