drugset / Trial / NCT07374224

A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet

NCT07374224 ↗

Phase 1 Recruiting 28 enrolled Guangzhou Lupeng Pharmaceutical Company LTD.
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

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg —
Subject Rifampicin Small molecule 600 mg —
Subject Rocbrutinib Small molecule 100 mg —
Subject Rocbrutinib Small molecule 200 mg —

Indications

No indication recorded.