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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
Scientific title
A Double-blind, Randomised, Controlled, 3 Cohort, Dose ranging, Crossover, Pharmacokinetic and Pharmacodynamic Study of Two Preparations of Pegfilgrastim in Healthy Subjects
Secondary ID [1] 281024 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastim in healthy volunteers 287157 0
Condition category
Condition code
Other 287478 287478 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285484 0
Treatment: Drugs
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)
Control group
Active

Outcomes
Primary outcome [1] 287743 0
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.
Timepoint [1] 287743 0
Time = 56 days
Secondary outcome [1] 298760 0
To compare additional PD measures of cell response of DRL pegfilgrastim to the RMP-Neulasta (registered trademark) from analysis of blood samples.
Timepoint [1] 298760 0
Time = 56 days
Secondary outcome [2] 298951 0
To compare the immunogenicity of two preparations of pegfilgrastim from analysis of blood samples.
Timepoint [2] 298951 0
Time = 56 days

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.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285810 0
Commercial sector/Industry
Name [1] 285810 0
Dr. Reddy's Laboratories (DRL)
Address [1] 285810 0
Survey No. 47, Bachupalli, Qutubullapur
R. R. Dist 500 090, Andhra Pradesh, India
Country [1] 285810 0
India
Primary sponsor type
Commercial sector/Industry
Name
Dr. Reddy’s Laboratories (DRL)
Address
Survey No. 47, Bachupalli, Qutubullapur
R. R. Dist – 500 090, Andhra Pradesh, India
Country
India
Secondary sponsor category [1] 284635 0
Commercial sector/Industry
Name [1] 284635 0
Quintiles Pty. Ltd.
Address [1] 284635 0
Level 10 67 Albert Avenue
Chatswood, New South Wales 2067
Country [1] 284635 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287825 0
The Alfred Hospital Research and Ethics Unit
Ethics committee address [1] 287825 0
55 Commercial Road, Melbourne, Victoria 3004
Ethics committee country [1] 287825 0
Australia
Date submitted for ethics approval [1] 287825 0
23/07/2012
Approval date [1] 287825 0
30/08/2012
Ethics approval number [1] 287825 0

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.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 34573 0
Dr Jason Lickliter
Address 34573 0
Nucleus Network
Level 5, Burnet Tower, AMREP Precinct,
89 Commercial Road
Melbourne, Victoria 3004, Australia
Country 34573 0
Australia
Phone 34573 0
+ 613 8593 9800
Fax 34573 0
Email 34573 0
J.Lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 17820 0
Mr Shivkumar Madki, Dr. Reddy’s Laboratories (DRL)
Address 17820 0
Survey No. 47, Bachupalli, Qutubullapur, R. R. Dist – 500 090, Andhra Pradesh
Country 17820 0
India
Phone 17820 0
+91-40-4464-4000
Fax 17820 0
+91-40-2304-1418
Email 17820 0
shivkumarm@drreddys.com
Contact person for scientific queries
Name 8748 0
Mr Shivkumar Madki, Dr. Reddy’s Laboratories (DRL)
Address 8748 0
Survey No. 47, Bachupalli, Qutubullapur, R. R. Dist – 500 090, Andhra Pradesh
Country 8748 0
India
Phone 8748 0
+91-40-4464-4000
Fax 8748 0
+91-40-2304-1418
Email 8748 0
shivkumarm@drreddys.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary