drugset / Trial / NCT00608907
An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
Phase 1
Completed
61 enrolled
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-09
- Primary completion
- 2010-03
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 40 mg | — |
| Subject | Rifampicin | Small molecule | 600 mg | — |