An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
The primary purpose of this Phase I study is to evaluate the effect of the co-administration
of CYP3A4 inducers on the pharmacokinetics profile of VELCADE (bortezomib). Rifampicin will
be used to assess the effect of a strong CYP3A4 inducer and dexamethasone to assess the
effect of a relatively weak inducer. This study is also to evaluate the impact of CYP3A4
inducers on the pharmacodynamics (PD) of VELCADE and the safety profile of VELCADE.
Phase:
Phase 1
Details
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.