drugset / Trial / NCT07374224
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I, open-label, two-part, fixed-sequence drug interaction study conducted to evaluate the effects of concomitant use of the potent CYP3A4 inhibitor itraconazole or the CYP3A4 inducer rifampin on the pharmacokinetics of Rocbrutinib in healthy subjects.
Timeline
- Start
- 2026-03-05
- Primary completion
- 2026-06-30
- Completion
- 2026-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | 200 mg | — |
| Subject | Rifampin | Small molecule | 600 mg | — |
| Subject | Rocbrutinib | Small molecule | 100 mg | — |
| Subject | Rocbrutinib | Small molecule | 200 mg | — |
Indications
No indication recorded.