The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
NCT Number: NCT05316857
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Suzhou, Jiangsu, 215000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orelabrutinib + Rifampin
Orelabrutinib + Itraconazole
Time frame: up to 3 months
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
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
To evaluate the safety and tolerability of Orelabrutinib
Beijing InnoCare Pharma Tech Co., Ltd.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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