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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
Orelabrutinib + Rifampin
Orelabrutinib + Itraconazole
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Cmax
To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)
Time frame: up to 3 months
Tmax
To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include Time to Maximum Plasma Concentration(Tmax)
Time frame: up to 3 months
Incidence of Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of Orelabrutinib
Time frame: up to 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.