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Trial registered on ANZCTR
Registration number
ACTRN12612000920897
Ethics application status
Approved
Date submitted
13/08/2012
Date registered
28/08/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A clinical trial to compare the pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastim
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Scientific title
A Double-blind, Randomised, Controlled, 3 Cohort, Dose ranging, Crossover, Pharmacokinetic and Pharmacodynamic Study of Two Preparations of Pegfilgrastim in Healthy Subjects
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Secondary ID [1]
281024
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastim in healthy volunteers
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Condition category
Condition code
Other
287478
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Comparative Dose ranging study (comparing Dr Reddy's Labs [DRL's] pegfilgrastim & Reference Medicinal Product [RMP] - Neulasta [registered trademark], a different preparation of pegfilgrastim) in a single dose, cross over design with 28 days wash out, with 3 cohorts (30,60 & 100mcg/kg by Subcutaneous [SC] injection). All participants at each dose cohort will receive both formulations of pegfilgrastim, 28 days apart.
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Intervention code [1]
285484
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Treatment: Drugs
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Comparator / control treatment
Neulasta. This is a comparative Dose ranging study (comparing DRL pegfilgrastim & RMP - Neulasta [registered trademark]) in a single dose cross over design with 28 days wash out with 3 cohorts (30,60 & 100mcg/kg SC)
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Control group
Active
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Outcomes
Primary outcome [1]
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To compare the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of 2 preparations of pegfilgrastim; i.e., DRL pegfilgrastim and the RMP - Neulasta (registered trademark) from analysis of blood samples.
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Assessment method [1]
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Timepoint [1]
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Time = 56 days
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Secondary outcome [1]
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To compare additional PD measures of cell response of DRL pegfilgrastim to the RMP-Neulasta (registered trademark) from analysis of blood samples.
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Assessment method [1]
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Timepoint [1]
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Time = 56 days
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Secondary outcome [2]
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To compare the immunogenicity of two preparations of pegfilgrastim from analysis of blood samples.
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Assessment method [2]
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Timepoint [2]
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Time = 56 days
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Eligibility
Key inclusion criteria
- Healthy male and female subjects
- In general good health
-Must have normal organ function; including normal liver and renal function
-Non-smokers or ex-smokers who have not smoked within the previous 6 months from Screening visit.
-Subjects must be able to understand and willing to comply with the study procedures, restrictions and requirements as judged by the investigator.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Known hypersensitivity to Escherichia coli derived proteins and/or hypersensitivity to the study drug pegfilgrastim or filgrastim or any of its ingredients.
- History of hypersensitivity to latex.
- Any prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or pegfilgrastim; or prior immunoglobulin preparations within the previous 6 months from Screening visit.
Hereditary fructose intolerance.
- Any clinically significant laboratory findings (haematology, biochemistry and urinalysis) outside the normal laboratory range of the test laboratory (where the test will be conducted).
- Any psychological, familial, sociological, personal (including out of town trips) or geographical conditions that do not permit compliance with the Clinical Study Protocol.
- Hypertension, significant hypercholesterolemia as judged by the investigator, or thyroid abnormalities.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible healthy subjects will be randomized into 3 cohorts in this comparative dose ranging study to receive DRL pegfilgrastim and RMP Neulasta (registered trademark) in a cross over manner. All eligible healthy subjects will be randomized by an unblinded Pharmacist not involved in other trial activities, using a pre-defined code into 3 cohorts to receive study drug and RMP in a double blind cross over manner.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be equally randomized using a permuted block randomisation, stratified by age and gender into one of three dose cohorts, and equally randomized within cohorts for the two treatment sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics / pharmacodynamics
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/10/2012
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Actual
24/10/2012
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Date of last participant enrolment
Anticipated
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Actual
9/11/2012
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Date of last data collection
Anticipated
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Actual
15/03/2013
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Sample size
Target
36
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Dr. Reddy's Laboratories (DRL)
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Address [1]
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Survey No. 47, Bachupalli, Qutubullapur
R. R. Dist 500 090, Andhra Pradesh, India
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Country [1]
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India
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Primary sponsor type
Commercial sector/Industry
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Name
Dr. Reddy’s Laboratories (DRL)
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Address
Survey No. 47, Bachupalli, Qutubullapur
R. R. Dist – 500 090, Andhra Pradesh, India
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Country
India
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Quintiles Pty. Ltd.
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Address [1]
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Level 10 67 Albert Avenue
Chatswood, New South Wales 2067
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Alfred Hospital Research and Ethics Unit
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Ethics committee address [1]
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55 Commercial Road, Melbourne, Victoria 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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23/07/2012
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Approval date [1]
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30/08/2012
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Ethics approval number [1]
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Summary
Brief summary
This is a crossover dose ranging study to assess and compare the PK/PD, immunogenicity and safety profiles of two preparations of Pegfilgrastim.
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Trial website
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Trial related presentations / publications
None
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Public notes
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Contacts
Principal investigator
Name
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Dr Jason Lickliter
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Address
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Nucleus Network
Level 5, Burnet Tower, AMREP Precinct,
89 Commercial Road
Melbourne, Victoria 3004, Australia
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Country
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Australia
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Phone
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+ 613 8593 9800
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Shivkumar Madki, Dr. Reddy’s Laboratories (DRL)
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Address
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Survey No. 47, Bachupalli, Qutubullapur, R. R. Dist – 500 090, Andhra Pradesh
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Country
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India
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Phone
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+91-40-4464-4000
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Fax
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+91-40-2304-1418
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Shivkumar Madki, Dr. Reddy’s Laboratories (DRL)
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Address
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Survey No. 47, Bachupalli, Qutubullapur, R. R. Dist – 500 090, Andhra Pradesh
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Country
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India
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Phone
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+91-40-4464-4000
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Fax
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+91-40-2304-1418
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Email
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[email protected]
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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.
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