Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000307707
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
20/03/2013
Date last updated
20/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A new treatment for malaria by an old drug (Griseofulvin).
Scientific title
Pharmacokinetic evaluation of Griseofulvin in healthy volunteers.
Secondary ID [1] 281919 0
Nil
Universal Trial Number (UTN)
U1111-1139-4118
Trial acronym
GT-BSPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 288315 0
Condition category
Condition code
Infection 288671 288671 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a trial to test two regimen of griseofulvin administration. Each of the two regimen will be performed on different volunteers.
This is done in healthy volunteers.

Blood will be used to measure griseofulvin levels in red cells and to measure haematological and clinical biochemical parameters. Blood will also be used to test infection rate using malarial parasites (In vitro).

The first regimen a unique (once-off) dose of 2g griseofulvin.

The second regimen is 500mg griseofulvin twice daily for 5 days.

Griseofulvin will be administered orally, by tablet.
Intervention code [1] 286482 0
Treatment: Drugs
Comparator / control treatment
Neither of these is a comparator arm. This is a pharmacokinetics trial only. We are testing for half life of griseofulvin in the red cells of treated people. The two regimen will give two different profiles.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288821 0
Ability of griseofulvin to inhibit the growth of malaria in blood taken from volunteers given the drug. Blood is taken from the volunteers and a portion added to infected red cells in culture. The kinetics of parasite growth is an indication of the ability of the erythrocytes taken from the volunteer to support infection. Parasitaemia is assessed by either fluorescent activated cell sorting or by counting Giemsa-stained thin smears.
Timepoint [1] 288821 0
Kinetic endpoints. Study to be done over 7 days. Endpoints are Days 1 through 7 for the malaria inhibition.
Primary outcome [2] 289108 0
Pharmacokinetic analysis of griseofulvin in red cells.
Timepoint [2] 289108 0
Red cells will be taken each day for the 5 days of the trial and griseofulvin will be measured.
Primary outcome [3] 289109 0
Cliinical chemistry and haematology after for the two trial regimen.
Timepoint [3] 289109 0
Days 1, 7 and 14
Secondary outcome [1] 301064 0
N/A
Timepoint [1] 301064 0
N/A

Eligibility
Key inclusion criteria
Never had malaria
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Female, planning to have children within 6 months, liver disease, co-morbidity

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)
Enrolment will be done through advertisement within the School of Medicine at Macquarie University. Assigment to treatment will be done consequentially
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consequentially.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
There are two groups of volunteers. One will be receiving a once-off, unique dose of 2g griseofulvin. The other group will be receiving 500mg bd for 5 days. These volunteers will be assigned to each group based on recruitment order.
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6298 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 286707 0
Government body
Name [1] 286707 0
NHMRC (National Health and Medical Research Council0
Country [1] 286707 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University,
2 Technology Place
Macquarie University 2109
New South Wales
Country
Australia
Secondary sponsor category [1] 285479 0
None
Name [1] 285479 0
NA
Address [1] 285479 0
NA
Country [1] 285479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288775 0
Macquarie University Clinical Ethics Committee
Ethics committee address [1] 288775 0
Macquarie University
NSW 2109
Australia
Ethics committee country [1] 288775 0
Australia
Date submitted for ethics approval [1] 288775 0
08/02/2013
Approval date [1] 288775 0
19/03/2013
Ethics approval number [1] 288775 0
REF 5201300061

Summary
Brief summary
Griseofulvin inhibits ferrochelatase (FECH). Inhibition of FECH in the red cell prevents the growth of malarial parasites. We plan a trial using griseofulvin to treat volunteers infected with malaria. This current proposed trial is a pharmacokinetics trial with two different regimen of griseofulvin, 500mg bd or a one-off bolus of 2g. The concentration of griseofulvin in red cells will be measured daily as will the ability of malarial parasites to infect cells taken from griseofulvin-treated volunteers. Haematological and clinical biochemical parameters will be followed.
Trial website
N/A
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 37706 0
Prof Simon Foote
Address 37706 0
Australian School of Advanced Medicine (ASAM)
2 Technology Place
Macquarie University
NSW 2109
Country 37706 0
Australia
Phone 37706 0
+61 2 98123517
Fax 37706 0
Email 37706 0
simon.foote@mq.edu.au
Contact person for public queries
Name 37707 0
Mrs Ceri Flowers
Address 37707 0
ASAM
2 Technology Place
Macquarie University
NSW 2109
Country 37707 0
Australia
Phone 37707 0
+61 2 98123517
Fax 37707 0
Email 37707 0
ceri.flowers@mq.edu.au
Contact person for scientific queries
Name 37708 0
Prof Simon Foote
Address 37708 0
ASAM
2 Technology Place
Macquarie University
NSW 2109
Country 37708 0
Australia
Phone 37708 0
+61298123500
Fax 37708 0
Email 37708 0
simon.foote@mq.edu.au

No information has been provided regarding IPD availability


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.