NCT05316857

DDI Study of Orelabrutinib

A Phase I, Single-center, Open-label, Fixed-sequence Clinical Study to Evaluate the Effects of Multiple Administrations of Rifampin or Itraconazole on the Pharmacokinetic Characteristics of a Single Administration of Orelabrutinib Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects.

Conditions

• Healthy Person

Interventions

Type	Name	Description
DRUG	Orelabrutinib + Rifampin	Orelabrutinib + Rifampin
DRUG	Orelabrutinib + Itraconazole	Orelabrutinib + Itraconazole

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-01-04
• Completion: 2022-06-13
• First posted: 2022-04-07
• Last updated: 2022-07-06

Locations

1 site across 1 country: China