First human trial of FTY720, a novel immunomodulator, in stable renal transplant patients

K Budde, RL Schmouder, R Brunkhorst… - Journal of the …, 2002 - journals.lww.com
FTY720 is a novel immunomodulator to be developed for use in organ transplantation. The
primary objective of this study was to measure safety, single-dose pharmacokinetics, and
pharmacodynamics in stable renal transplant patients—the first human use of FTY720. This
study used a randomized, double-blind, placebo-controlled design that explored single oral
doses of FTY720 from 0.25 to 3.5 mg in 20 stable renal transplant patients on a cyclosporine-
based regimen. Safety assessments and blood samples were taken predose and at multiple …