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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.
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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.
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Secondary ID [1]
306856
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None
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Universal Trial Number (UTN)
U1111-1268-3672
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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:
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).
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Condition category
Condition code
Oral and Gastrointestinal
323262
323262
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0
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Crohn's disease
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Oral and Gastrointestinal
323263
323263
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
323325
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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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
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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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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
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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
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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 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
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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)
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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer
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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
Pharmacokinetics
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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
18/07/2022
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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
14
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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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Douglas Pharmaceuticals Limited
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Address [1]
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Central Park Drive
PO Box 45-027
Auckland
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Country [1]
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New Zealand
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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
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]
312538
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Health and 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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14/04/2021
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Approval date [1]
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12/05/2021
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Ethics approval number [1]
310709
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21/CEN/117
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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.
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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 Corp Ltd
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 Corp Ltd
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 Corp Ltd
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
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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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