A Study of Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral Dose
Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
Participant gender:
Summary
The purposes of this study are to investigate the metabolic pathways of paliperidone and
excretion of paliperidone and its metabolites in healthy adult male volunteers, both CYP2D6
poor and extensive metabolizers, after administration of a single 1-mg oral dose of
14C-paliperidone, to evaluate the safety and tolerability of paliperidone, and to determine
the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure
to paliperidone and its metabolites.
Phase:
Phase 1
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.