Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000410550
Ethics application status
Approved
Date submitted
19/09/2006
Date registered
19/09/2006
Date last updated
19/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of AV411 in Healthy Subjects
Scientific title
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Center Trial to Assess the Safety, Tolerability, and Pharmacokinetics of AV411 in Healthy Subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects 1377 0
Condition category
Condition code
Other 1470 1470 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose oral AV411 (30 mg) on Study day 1
Oral AV411 (30 mg) twice daily for 14 days beginning on Study day 3
Intervention code [1] 1353 0
Treatment: Drugs
Comparator / control treatment
Placebo on Study day 1
Placebo twice daily for 14 days beginning on Study day 3
Control group
Placebo

Outcomes
Primary outcome [1] 2033 0
Safety and tolerability of AV411 at a single dose level in healthy subjects
Timepoint [1] 2033 0
Daily
Secondary outcome [1] 3519 0
Plasma collection for pharmacokinetic sampling
Timepoint [1] 3519 0
On Study days 2, 3, 5, 10, 13, 17 and 20
Secondary outcome [2] 3520 0
Full pharmacokinetic analysis
Timepoint [2] 3520 0
On Study days 1, 6 and 16.
Secondary outcome [3] 3521 0
Urine collection for metabolite analyses
Timepoint [3] 3521 0
On Study days 1, 6, 16 and 20.

Eligibility
Key inclusion criteria
Nonsmoking.-No clinical abnormality in laboratory and urine analyses.-Normal renal function Glomerular Filtration Rate (GFR) >90 mL/min.-Liver enzymes less than twice the upper limit of normal.-Electrocardiogram within normal limits at screening.-Willing to use barrier contraceptive during the period of the study.-Negative pregnancy test on Study Day 1 for female subjects of child-bearing potential.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known hypersensitivity to Pinatos or its components.-Conditions which might affect drug absorption, metabolism or excretion.-Untreated mental illness, current drug addiction or abuse or alcoholism.-Donated blood in the past 90 days or have poor peripheral venous access.-Platelets <100,000 per mm3 or a history of thrombocytopenia.-Confirmed diagnosis of chronic liver disease.-Positive for HIV.-Female subjects who are pregnant or nursing mothers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Off-site holder of allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pharmacist is unblinded. Subject and and all other study personnel are blinded
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1609 0
Commercial sector/Industry
Name [1] 1609 0
Avigen, Inc.
Country [1] 1609 0
Primary sponsor type
Commercial sector/Industry
Name
Avigen, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 1412 0
None
Name [1] 1412 0
None
Address [1] 1412 0
Country [1] 1412 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27960 0
Address 27960 0
Country 27960 0
Phone 27960 0
Fax 27960 0
Email 27960 0
Contact person for public queries
Name 10542 0
Charlotte Goess
Address 10542 0
CMAX (A Division of IDT Australia LTD)
Royal Adelaide Hospital
Level 5 East Wing
North Terrace Adelaide SA 5000
Country 10542 0
Australia
Phone 10542 0
+61 8 84163100
Fax 10542 0
+61 8 83618615
Email 10542 0
charlotte.goess@cmax.com.au
Contact person for scientific queries
Name 1470 0
Tamara Murdock
Address 1470 0
CMAX (A Division of IDT Australia LTD)
Royal Adelaide Hospital
Level 5 East Wing
North Terrace Adelaide SA 5000
Country 1470 0
Australia
Phone 1470 0
+61 8 84163144
Fax 1470 0
+61 8 83618615
Email 1470 0
tamara.murdock@cmax.com.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.