Crossover study of the haematological effects and pharmacokinetics of glycosylated and non-glycosylated G-CSF in healthy volunteers

Br J Haematol. 1997 Aug;98(2):474-9. doi: 10.1046/j.1365-2141.1997.2393053.x.

Abstract

A cross-over study of glycosylated and non-glycosylated G-CSF was performed in 20 healthy male volunteers to compare the effects of the different forms of G-CSF, the extent of inter-individual progenitor cell mobilization and to determine whether any differences observed were related to the serum concentrations of G-CSF attained. The peak WBC achieved during 6 d of G-CSF administration at a dose of 5 microg/kg/d was significantly higher with the glycosylated than the non-glycosylated product (P = 0.02) as was the peak level of granulocyte-monocyte colony forming cells (GM-CFC) (P=0.03). The average GM-CFC count on days 5, 6 and 7 was 28% higher with the glycosylated product (P=0.003). Serum concentrations of G-CSF achieved were significantly higher with the non-glycosylated G-CSF, however, suggesting that the difference in bio-efficacy was not due to a difference in G-CSF stability. Marked inter-individual variation in progenitor mobilization was observed, but this was not related to serum G-CSF levels. The G-CSF concentrations on day 6 were approximately one third of those on day 1, with both forms of G-CSF.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / pharmacokinetics
  • Adjuvants, Immunologic / pharmacology*
  • Adult
  • Antigens, CD34 / metabolism
  • Cell Division
  • Cross-Over Studies
  • Double-Blind Method
  • Filgrastim
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Granulocyte Colony-Stimulating Factor / pharmacokinetics
  • Granulocyte Colony-Stimulating Factor / pharmacology*
  • Humans
  • Lenograstim
  • Leukocyte Count
  • Leukocytes, Mononuclear / cytology*
  • Leukocytes, Mononuclear / metabolism
  • Male
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / pharmacokinetics
  • Recombinant Proteins / pharmacology
  • Stem Cells* / cytology
  • Stem Cells* / metabolism

Substances

  • Adjuvants, Immunologic
  • Antigens, CD34
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Lenograstim
  • Filgrastim