A clinical trial to compare the pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastim

A Double-blind, Randomised, Controlled, 3 Cohort, Dose ranging, Crossover, Pharmacokinetic and Pharmacodynamic Study of Two Preparations of Pegfilgrastim in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000920897

Enrollment

Registered

2012-08-28

Start date

2012-10-24

Completion date

2012-11-09

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

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.

Outcome results