CROSSOVER STUDY OF THE HEMATOLOGICAL EFFECTS AND PHARMACOKINETICS OF GLYCOSYLATED AND NONGLYCOSYLATED G-CSP IN HEALTHY-VOLUNTEERS

A cross-over study of glycosylated and nonglycosylated G-CSF was perfo rmed in 20 healthy male volunteers to compare the effects of the diffe rent forms of G-CSE the extent of inter-individual progenitor cell mob ilization and to determine whether any differences observed were relat ed to the serum concentrations of G-CSF attained. The peak WBC achieve d during 6d of G-CSF administration at a dose of 5 mu g/kg/d was signi ficantly higher with the glycosylated than the non-glycosylated produc t (P = 0.02) as was the peak level of granulocyte;monocyte colony form ing 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 conce ntrations of G-CSF achieved were significantly higher with the non-gly cosylated G-CSE however, suggesting that the difference in bio-efficac y was not due to a difference in G-CSF stability. Marked inter-individ ual variation in progenitor mobilization was observed, but this was no t related to serum G-CSF levels, The G-CSF concentrations on day 6 wer e approximately one third of those on day 1, with both forms of G-CSE.