drugset / Trial / NCT02381080
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the effect of a moderate Cytochrome P450 (CYP) 3A inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state pharmacokinetics (PK \[the study of the way a drug enters and leaves the blood and tissues over time\]) of repeated oral doses of ibrutinib in participants with B-cell malignancy (cancer or other progressively enlarging and spreading tumors).
Timeline
- Start
- 2015-05-19
- Primary completion
- 2016-06-24
- Completion
- 2016-06-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erythromycin | Small molecule | 500 mg | Oral |
| Subject | Ibrutinib | Small molecule | 140 mg | Oral |
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Subject | Voriconazole | Small molecule | 200 mg | Oral |