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Trial registered on ANZCTR


Registration number
ACTRN12617001346369
Ethics application status
Approved
Date submitted
17/09/2017
Date registered
25/09/2017
Date last updated
3/12/2020
Date data sharing statement initially provided
5/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single dose study of febuxostat (80 mg) in healthy subjects.
Scientific title
The pharmacokinetics and pharmacodynamics of a single dose of febuxostat (80 mg) in healthy subjects.
Secondary ID [1] 292905 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic gout 304753 0
Condition category
Condition code
Musculoskeletal 304080 304080 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy subjects will be orally administered a single dose of febuxostat (80 mg). Urine (total catch) and blood samples will be collected at baseline (before administrating the dose) and for 102 hours post dose administration.
No adherence assessment is required in this single dose study.
Intervention code [1] 299136 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303398 0
Examine the pharmacokinetics ([Cmax], time to reach Cmax [tmax], apparent clearance, apparent volume of distribution and half-life) of a single dose of febuxostat (80 mg) in healthy subjects. Blood samples will be collected immediately pre- dose and at the following times after dose administration: 1, 3, 6, 9, 24, 31, 48, 72, 96 and 102 hours. Plasma febuxostat will be determined by a HPLC method.
Timepoint [1] 303398 0
The plasma concentrations of febuxostat will be determined pre-dose and at the following times after dose administration: 1, 3, 6, 9, 24, 31, 48, 72, 96 and 102 hours.
Primary outcome [2] 303435 0
Examine the change in serum urate over 102 hours following the administration of a single dose of febuxostat (80 mg) in healthy subjects. Blood samples will be collected immediately pre- dose and at the following times after dose administration: 1, 3, 6, 9, 24, 31, 48, 72, 96 and 102 hours. Serum urate will be determined by the uricase method (St Vincent's pathology, Sydpath).
Timepoint [2] 303435 0
The concentrations of serum urate will be measured immediately pre- dose and at the following times after dose administration: 1, 3, 6, 9, 24, 31, 48, 72, 96 and 102 hours.
Secondary outcome [1] 338834 0
Investigate the effect of a single dose of febuxostat (80 mg) on the renal handling of urate (fractional clearance of urate). Uric acid and creatinine will be measured by the Uricase method (Sydpath) and the Jaffe reaction (Sydpath), respectively. Blood and urine samples will be collected before administering a single dose of febxuostat (80 mg) and for 102 hour post dose administration. The serum and urinary urate and creatinine will be used to calculate the fractional clearance of urate pre and post dose administration.
Timepoint [1] 338834 0
Blood samples will be collected immediately pre- dose and at the following times after dose administration: 1, 3, 6, 9, 24, 31, 48, 72, 96 and 102 hours. Urine (total catch) will be collected 24 hour pre dose and at the following times after dose administration: 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36, 36-48, 72, 96 and 101-102. hours. Serum and urinary urate and creatinine concentrations will be measured at baseline and over 102 hours following the administration of a single dose of febuxostat (80 mg).

Eligibility
Key inclusion criteria
Healthy subjects
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subject with a history of any chronic disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
A sample size of 10 participants was considered sufficient to explore the time course of the hypouricaemic effects of a single dose of febuxostat (80 mg) and the effect of a single dose of febuxostat (80 mg) on the renal handling of urate.
Febuxostat pharmacokinetic parameters (maximum plasma concentration [Cmax], time to reach Cmax [tmax], apparent clearance, apparent volume of distribution and half-life) will be determined. In addition, the concentration-time profile of serum urate concentrations over a period of 5 days after the administration of a single dose of febuxostat (80 mg) will be defined. Urate excretion rate will be estimated before and after febuxostat administration. Serum and urinary urate and ceratinine will be used to calculate the fractional clearance of urate (FCU). The effect of a single dose of febuxostat on the renal handling of urate will be explored and reported. The relationship between the plasma concentrations of febuxostat and response (in terms of serum uarte lowering) will be fitted using modelling techniques.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/07/2016
Date of last participant enrolment
Anticipated
8/03/2021
Actual
Date of last data collection
Anticipated
15/03/2021
Actual
Sample size
Target
10
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9043 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 17525 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 297535 0
Charities/Societies/Foundations
Name [1] 297535 0
Clinical Pharmacology Lexy Davies Trust Fund
Country [1] 297535 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
St Vincent's Hospital, 390 Victoria St, Darlinghurst, Australia, NSW 2010.
Country
Australia
Secondary sponsor category [1] 296542 0
None
Name [1] 296542 0
Address [1] 296542 0
Country [1] 296542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298630 0
St Vincent's Hospital, Sydney
Ethics committee address [1] 298630 0
390 Victoria Road, Darlinghurst, Australia, New South Wales 2010.
Ethics committee country [1] 298630 0
Australia
Date submitted for ethics approval [1] 298630 0
17/12/2015
Approval date [1] 298630 0
16/03/2016
Ethics approval number [1] 298630 0
HREC/15/SVH/423

Summary
Brief summary
Healthy subjects will be administered a single dose of febuxostat (80 mg) to examine the the pharmacokinetic and pharmacodynamic profiles of febuxostat following the administration of a single dose (80 mg). This study will also investigate the effect of a single dose of febuxostat (80 mg) on the renal handling of urate.
Trial website
None.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77706 0
Prof Richard Day
Address 77706 0
Department of Clinical Pharmacology and Toxicology, Level 2 Xavier Building, St Vincent's Hospital, 390 Victoria St, Darlinghurst, Australia, NSW 2010.
Country 77706 0
Australia
Phone 77706 0
+61, 2, 83822331
Fax 77706 0
+61, 2, 83822724
Email 77706 0
[email protected]
Contact person for public queries
Name 77707 0
Bishoy Kamel
Address 77707 0
Department of Clinical Pharmacology and Toxicology, Level 2 Xavier Building, St Vincent's Hospital, 390 Victoria St, Darlinghurst, Australia, NSW 2010.
Country 77707 0
Australia
Phone 77707 0
+61, 2, 83822051
Fax 77707 0
+61, 2, 83822724
Email 77707 0
[email protected]
Contact person for scientific queries
Name 77708 0
Richard Day
Address 77708 0
Department of Clinical Pharmacology and Toxicology, Level 2 Xavier Building, St Vincent's Hospital, 390 Victoria St, Darlinghurst, Australia, NSW 2010.
Country 77708 0
Australia
Phone 77708 0
+61, 2, 83822331
Fax 77708 0
+61, 2, 83822724
Email 77708 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
Although we are happy to share we have not asked permission of participants. We haven’t asked HREC either. So unable to share at present.



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
SourceTitleYear of PublicationDOI
EmbaseA pharmacokinetic-pharmacodynamic study of a single dose of febuxostat in healthy subjects.2020https://dx.doi.org/10.1111/bcp.14357
N.B. These documents automatically identified may not have been verified by the study sponsor.