J. Azuma et al., THE EFFECT OF Y-25510 INJECTION ON THE SERUM LEVELS OF SOME CYTOKINESIN HEALTHY ADULT VOLUNTEERS, European Journal of Clinical Pharmacology, 53(6), 1998, pp. 411-419
Objective: Y-25510 was administered by means of an intravenous drip in
fusion to healthy adult male volunteers at a dose of 40, 80 or 160 mg
in a single-dose study, and at a dose of 160 mg once a day for 7 days
in a multiple-dose study. Results: Serum levels of interleukin (IL)-1
beta, IL-6 and IL-10 were significantly increased, but there was no ch
ange in leukocyte and platelet counts. The peak serum concentration of
IL-1 beta was nearly maximum at the single doses of 40 and 80 mg, and
at the multiple dose of 160 mg per day. The peak serum concentration
of IL-6 increased in a dose-dependent manner at a dose of 40 mg or mor
e. For the multiple-dose study, the serum level of IL-10, which remain
ed unchanged in the placebo group, began to increase in the Y-25510 gr
oup following the maximum serum level of IL-1 beta and IL-6. There wer
e no clinically relevant differences in body temperature and blood pre
ssure after the administration of Y-25510. Conclusion: These findings
that leukocyte and platelet counts never increased, despite the increm
ent of the IL-1 beta and IL-6 production after the administration of Y
-25510, may be explained in part by the negative feedback mechanism in
duced by IL-10.