Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000240549
Ethics application status
Approved
Date submitted
5/06/2006
Date registered
15/06/2006
Date last updated
9/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase Ib Chronic Pharmacokinetic and Tolerability Study of Oral NV-52 in Normal Healthy Volunteers
Scientific title
Phase Ib Chronic Pharmacokinetic and Tolerability Study of Oral NV-52 in Normal Healthy Volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 1217 0
Condition category
Condition code
Other 1301 1301 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
NV-52 is an experimental drug which is being developed as an orally-delivered non-toxic agent being developed for the maintenance of remission in inflammatory bowel disease (IBD). The duration of intervention is 10 days at a dose of 400 mg per day with no control group.
Intervention code [1] 1123 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1780 0
(a) to determine whether NV-52 accumulates
Timepoint [1] 1780 0
Following 10 days of chronic oral dosing
Primary outcome [2] 1781 0
(b) to determine whether there is any change in the pharmacokinetics of NV-52
Timepoint [2] 1781 0
Following 10 days of chornic dosing
Secondary outcome [1] 3134 0
To investigate the effect of NV-52 on inflammatory markers in serum following 10 days of chronic dosing.
Timepoint [1] 3134 0
Following 10 days of chronic dosing

Eligibility
Key inclusion criteria
Adult patients will be enrolled who • are non-smokers• are on no regular medication (except the oral contraceptive pill - OCP)• have no chronic disease which requires regular therapy• a daily alcohol intake of < 40g• have no history of alcohol or other drug dependence.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the studyAlcohol consumption of > 40g per dayA history of alcohol or drug dependence within the last three yearsA chronic illness which requires regular therapyAsthmaPrevious hypersensitivity or allergy to aspirin or other anti-inflammatory agents Use of any prescription medication within the preceding week other than the oral contraceptive pillFemales not using adequate contraception.

Study design
Purpose of the study
Prevention
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
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1428 0
Commercial sector/Industry
Name [1] 1428 0
Novogen Research Pty Limited
Country [1] 1428 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Novogen Research Pty Limited
Address
140 Wicks Road
North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 1256 0
None
Name [1] 1256 0
Nil
Address [1] 1256 0
Country [1] 1256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2803 0
Pacific Private Hospital
Ethics committee address [1] 2803 0
Ethics committee country [1] 2803 0
Australia
Date submitted for ethics approval [1] 2803 0
Approval date [1] 2803 0
02/06/2006
Ethics approval number [1] 2803 0
R0521

Summary
Brief summary
The study is being conducted as the second study (Phase 1) in the clinical development of NV-52 as a new drug for inflammatory bowel disease. It is important to know that patients who are entered onto Phase I studies generally start with one dose of the drug(s) to be tested, then take doses of the drug over the following days. The purpose of the study is to determine the “bio-availability”, that is, can the drug be detected in blood or urine of NV-52 when administered orally (pill form). Also, to see if the drug is well tolerated in patients, without side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35804 0
Address 35804 0
Country 35804 0
Phone 35804 0
Fax 35804 0
Email 35804 0
Contact person for public queries
Name 10312 0
Dr Jan Howes
Address 10312 0
Pacific Private Hospital
(A subsidiary of Allamanda Hospital)
Southport, QLD 4215
Country 10312 0
Australia
Phone 10312 0
+61 7 55312971
Fax 10312 0
Email 10312 0
[email protected]
Contact person for scientific queries
Name 1240 0
Professor Laurie Howes
Address 1240 0
Pacific Private Hospital
(A subsidiary of Allamanda Hospital)
Southport QLD 4215
Country 1240 0
Australia
Phone 1240 0
+61 7 55718979
Fax 1240 0
Email 1240 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.