Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000579796
Ethics application status
Approved
Date submitted
7/04/2022
Date registered
20/04/2022
Date last updated
24/06/2022
Date data sharing statement initially provided
20/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative bioavailability assessment between 2 x 10 mg R-178 tablets and 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione tablets administered orally in healthy participants under fasting conditions.
Scientific title
A single dose, randomised, 2-period, 2-sequence, crossover, relative bioavailability study comparing 2 x 10 mg R-178 tablets with 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione tablets administered orally in healthy participants under fasting conditions.
Secondary ID [1] 306856 0
None
Universal Trial Number (UTN)
U1111-1268-3672
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
2-amino-1,7-dihydro-6H-purine-6-thione is indicated for the maintenance treatment of inflammatory bowel disease (Crohn's disease or ulcerative colitis). 325951 0
Condition category
Condition code
Oral and Gastrointestinal 323262 323262 0 0
Crohn's disease
Oral and Gastrointestinal 323263 323263 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 2 x 10 mg R-178 tablets on one occasion and the reference formulation 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione tablets on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test R-178 formulation.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the oral 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. Bathroom visits will be supervised during the first 5 hours. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 32 hours after dosing.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and drugs of abuse test 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.

Both doses will be taken orally with 240 ml of water at ambient temperature. The 2-amino-1,7-dihydro-6H-purine-6-thione tablets must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.
Intervention code [1] 323325 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives 2 x 10 mg R-178 tablets on one occasion and the 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione tablets on one occasion with each dose separated by a two week washout period. The comparator/control for this trial is the innovator 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione formulation.
Control group
Active

Outcomes
Primary outcome [1] 331005 0
To evaluate the pharmacokinetics (as summarised by Cmax and AUC). All plasma samples will be assayed for 2-amino-1,7-dihydro-6H-purine-6-thione using fully validated LC/MS/MS methods. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 331005 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, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24 and 32 hours post dosing
Secondary outcome [1] 408461 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] 408461 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, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24 and 32 hours post dosing

Eligibility
Key inclusion criteria
Healthy participants.
Aged between 18 and 55
Non-smoker
BMI between 18 and 30
Healthy individuals in good health as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
The absence of mental illness requiring medication or treatment by a physician.
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 history of mental illness requiring medication or treatment by a physician.
A deficient, low or intermediate TPMT ensyme activity by means of phenotyping found during medical screening
History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
History of Gilbert's Syndrome or Gout
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Smoker (anyone who has smoked in the last 6 months)
Participants of child- bearing potential who are pregnant and/or breastfeeding
History of alcohol 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)
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. Unblinding can be conducted by the Managing Director only in the appropriate circumstances (e.g. a SAE) and the procedure for this will involve referring to the Randomisation File that is kept separately from the Study Master File in a restricted access file limited to the Principal Investigator.
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
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment outside Australia
Country [1] 24711 0
New Zealand
State/province [1] 24711 0
Otago

Funding & Sponsors
Funding source category [1] 311178 0
Commercial sector/Industry
Name [1] 311178 0
Douglas Pharmaceuticals Limited
Country [1] 311178 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 312538 0
None
Name [1] 312538 0
Address [1] 312538 0
Country [1] 312538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310709 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310709 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 310709 0
New Zealand
Date submitted for ethics approval [1] 310709 0
14/04/2021
Approval date [1] 310709 0
12/05/2021
Ethics approval number [1] 310709 0
21/CEN/117

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation R-178 tablets relative to that of the reference formulation 2-amino-1,7-dihydro-6H-purine-6-thione tablets in fasting conditions.

In this study we will measure how much 2-amino-1,7-dihydro-6H-purine-6-thione is absorbed into the bloodstream and compare the concentrations between the test and reference formulations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118594 0
Dr Noelyn Hung
Address 118594 0
Zenith Technology Corp Ltd
156 Frederick Street, (PO Box 1777)
Dunedin 9016
Country 118594 0
New Zealand
Phone 118594 0
+64 21 482 148
Fax 118594 0
+64 3 477 9605
Email 118594 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 118595 0
Mrs Linda Folland
Address 118595 0
Zenith Technology Corp Ltd
156 Frederick Street, (PO Box 1777)
Dunedin 9016
Country 118595 0
New Zealand
Phone 118595 0
+64 3 477 9669
Fax 118595 0
+64 3 477 9605
Email 118595 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 118596 0
Dr Tak Hung
Address 118596 0
Zenith Technology Corp Ltd
156 Frederick Street, (PO Box 1777)
Dunedin 9016
Country 118596 0
New Zealand
Phone 118596 0
+64 3 477 9669
Fax 118596 0
+64 3 477 9605
Email 118596 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.