Pharmacokinetics of recombinant human interleukin‐11 (rhIL‐11) in healthy male subjects

Abstract
Aims To study the pharmacokinetics of recombinant human interleukin‐11 (rhIL‐11) in healthy male volunteers following subcutaneous (s.c.) and intravenous (i.v.) administration. Methods RhIL‐11 was infused intravenously at 10–50 μg kg−1 for 1 or 3 h, or administered subcutaneously at 3–50 μg kg−1 to volunteers. RhIL‐11 was also administered at 3 μg kg−1 s.c. once daily for 7 days. Plasma and urinary concentrations were measured by enzyme‐linked immunosorbent assay (ELISA). Results RhIL‐11 showed linear pharmacokinetics after both intravenous infusion and s.c. administration. Comparison of t1/2 and MRT values after i.v. administration with those after s.c. administration indicated that rhIL‐11 pharmacokinetics after s.c. administration were absorption rate‐limited. Bioavailability after s.c. administration was about 65%. Since RhIL‐11 was not detected in urine after a single 50 μg kg−1 s.c. dose, rhIL‐11 was considered to be eliminated by metabolism. There was no significant change in the pharmacokinetic profile of rhIL‐11 following repeated s.c. administration. Conclusions RhIL‐11 demonstrated linear pharmacokinetics at these dose ranges after single and repeated s.c. administration or constant‐rate i.v. infusion in healthy volunteers.

This publication has 0 references indexed in Scilit: