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Trial registered on ANZCTR


Registration number
ACTRN12621000332820
Ethics application status
Approved
Date submitted
23/02/2021
Date registered
24/03/2021
Date last updated
21/03/2022
Date data sharing statement initially provided
24/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative assessment in healthy male volunteers under fasting conditions of the absorption and pharmacokinetics of 1 generic formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsule against the innovator (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsule
Scientific title
A single dose, open label, balanced, randomized, 2 treatment, four period, two sequence, four-way, fully replicated crossover bioequivalence study of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsules against the innovator (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsule conducted under fasting conditions in healthy male volunteers
Secondary ID [1] 303504 0
None
Universal Trial Number (UTN)
U1111-1264-2780
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Is used in the treatment of severe psoriasis in adult patients who have not responded to standard treatments. 320840 0
Condition category
Condition code
Skin 318663 318663 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, four-way fully replicated crossover study whereby each participant receives the test formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid, 1 x 25 mg capsule on two occasions and the innovator formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid, 1 x 25 mg capsule on two occasions with each dose separated by a four week washout period. The intervention for this trial is the test formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid.

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 prior to 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 drugs of abuse testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing.

Pre and post study laboratory tests will be completed to assess the health of the participants.

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] 319803 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsules (1 x 25 mg) on two occasions and the innovator formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsules (1 x 25 mg) on two occasions with each dose separated by a four week washout period. The comparator/control for this trial is the innovator formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsules.
Control group
Active

Outcomes
Primary outcome [1] 326612 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 (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 326612 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post dosing
Secondary outcome [1] 392120 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] 392120 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post dosing

Eligibility
Key inclusion criteria
Healthy males
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 18 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
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females
Clinically significant medical conditions
History of depression or other psychiatric illness
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Sensitivities to Vitamin A
Participation in a drug study within 30 days of the start of the study
Sensitivities to (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid, its excipients or any other retinoids
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)
All formulations will be labeled as Formulation A and B. Treatments will be allocated randomly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be identified by 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 study number (randomisation number) after acceptance into the study. Randomization will be performed using a randomisation table created by computer software (i.e. computerized sequence generation).
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
Actual
19/03/2021
Date of last participant enrolment
Anticipated
24/03/2021
Actual
22/05/2021
Date of last data collection
Anticipated
15/06/2021
Actual
17/08/2021
Sample size
Target
30
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 23482 0
New Zealand
State/province [1] 23482 0
Otago

Funding & Sponsors
Funding source category [1] 307921 0
Commercial sector/Industry
Name [1] 307921 0
Alembic Pharmaceuticals Limited
Country [1] 307921 0
India
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
PO Box 1777
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 308638 0
None
Name [1] 308638 0
Address [1] 308638 0
Country [1] 308638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307919 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 307919 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6145
Ethics committee country [1] 307919 0
New Zealand
Date submitted for ethics approval [1] 307919 0
29/01/2021
Approval date [1] 307919 0
26/02/2021
Ethics approval number [1] 307919 0
21/STH/35

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 25 mg (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsule relative to that of the reference formulation (innovator brand of 25 mg (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsule ) following oral administration of a single dose of 25 mg in healthy male subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108930 0
Dr Noelyn Hung
Address 108930 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 108930 0
New Zealand
Phone 108930 0
+64 3 477 9669
Fax 108930 0
+64 3 477 9605
Email 108930 0
[email protected]
Contact person for public queries
Name 108931 0
Linda Folland
Address 108931 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 108931 0
New Zealand
Phone 108931 0
+64 3 477 9669
Fax 108931 0
+64 3 477 9605
Email 108931 0
[email protected]
Contact person for scientific queries
Name 108932 0
Tak Hung
Address 108932 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 108932 0
New Zealand
Phone 108932 0
+64 3 477 9669
Fax 108932 0
+64 3 477 9605
Email 108932 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.