Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000611426
Ethics application status
Approved
Date submitted
22/11/2007
Date registered
28/11/2007
Date last updated
30/06/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase Ia Pharmacokinetic and Tolerability Study of Oral NV-27 in Normal Healthy Volunteers
Scientific title
Phase Ia Pharmacokinetic and Tolerability Study of Oral NV-27 in Normal Healthy Volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety and tolerability of the investigational drug NV-27 in healthy male volunteers 2569 0
Condition category
Condition code
Other 2675 2675 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 healthy male volunteers will each take 400mg of study drug NV-27 once, orally on day 1. The participants will be closely monitored for 5 days to determine the pharmacokinetics and tolerability of NV-27. Participants will then be required to return 4 weeks after taking NV-27 to assess their tolerability and the safety of NV-27.
Intervention code [1] 2303 0
Treatment: Drugs
Comparator / control treatment
no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3581 0
To determine the pharmacokinetics of an acute dose of NV-27 administered orally.
Timepoint [1] 3581 0
To assess pharmacokinetics each participant will have blood collected prior to taking NV-27 and then at 10, 20, 30, 45, and 60 mins, 1.5h, 2h, 2.5h, 3h, 4h, 8h, 24h, and 72h following ingestion of NV-27.

In addition each participant will be required to collect urine prior to taking NV-27 and then collect all urine up to 96hrs following ingestion of NV-27.
Secondary outcome [1] 5996 0
To determine the safety and tolerability of an acute dose of NV-27 administered orally.
Timepoint [1] 5996 0
Participants will be monitored for safety and tolerability for 5 days following NV-27 ingestion. Participants will then be required to return 4 weeks after taking NV-27 to assess their tolerability and the safety of NV-27.

Eligibility
Key inclusion criteria
a) Normal healthy male volunteers
b) At screening, patients must have all clinical pathology analytes within the laboratory’s reference ranges
c) Participants must be 18 - 40 years of age
d) Non-smokers
e) Participants must be able to understand the risks and benefits of the study and give written informed consent to participation
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Participants who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the study
b) Alcohol consumption of > 40g per day
c) A history of alcohol or drug dependence within the last three years
d) A chronic illness which requires regular therapy
e) Asthma
f) Previous hypersensitivity or allergy to aspirin or other anti-inflammatory agents
g) Use of any prescription medication within the preceding week

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 333 0
4215

Funding & Sponsors
Funding source category [1] 2816 0
Commercial sector/Industry
Name [1] 2816 0
Novogen Research Pty Ltd
Country [1] 2816 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Novogen Research Pty Ltd
Address
140 Wicks Road
North Ryde
NSW 2113
Country
Australia
Secondary sponsor category [1] 2542 0
None
Name [1] 2542 0
Address [1] 2542 0
Country [1] 2542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4740 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 4740 0
Ethics committee country [1] 4740 0
Australia
Date submitted for ethics approval [1] 4740 0
21/11/2007
Approval date [1] 4740 0
13/12/2007
Ethics approval number [1] 4740 0
RO521(1)

Summary
Brief summary
This trial will involve 6 healthy male volunteers to determine the pharmacokinetics and safety/tolerability of the investigational drug NV-27.
Trial website
www.novogen.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28202 0
Address 28202 0
Country 28202 0
Phone 28202 0
Fax 28202 0
Email 28202 0
Contact person for public queries
Name 11359 0
Dr Jan Howes
Address 11359 0
Queensland Radiology
138 Queens Street
Southport
QLD 4215
Country 11359 0
Australia
Phone 11359 0
(07) 5519 8859
Fax 11359 0
Email 11359 0
[email protected]
Contact person for scientific queries
Name 2287 0
Professor Laurie Howes
Address 2287 0
Queensland Radiology
138 Queens Street
Southport
QLD 4215
Country 2287 0
Australia
Phone 2287 0
(07) 5571-8979
Fax 2287 0
Email 2287 0
[email protected]

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.