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Fruquintinib CYP3A Inhibitor and Inducer Study

Drug Drug Interaction Clinical Trial

Official title:
A Phase 1 Open-label 2-Part 2-Period Fixed-sequence Crossover Study To Assess The Effect Of Itraconazole, A Strong CYP3A Inhibitor, And The Effect Of Rifampin, A Strong CYP3A Inducer, On Pharmacokinetics Of Fruquintinib In Healthy Subjects

Clinical Trial Summary

A study to assess the effect of itraconazole, a strong CYP3A inhibitor, and the effect of rifampin, a strong CYP3A inducer, on the pharmacokinetics of fruquintinib in healthy subjects.

Clinical Trial Description

This study will be a single-center, open-label, 2-part, 2-period fixed sequence crossover study to be conducted with 28 healthy male and female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Period 1 and Period 2), and an End of Study (EOS) Phase. Screening will occur within 21 days before the first study drug administration. There will be at least a 14-day washout of fruquintinib between treatment periods. Part A: subjects will be administered fruquintinib alone in treatment Period 1 and in combination with itraconazole in treatment Period 2. Part B: subjects will be administered fruquintinib alone in treatment Period 1 and in combination with rifampin in treatment Period 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04557397
Study type Interventional
Source Hutchison Medipharma Limited
Contact
Status Completed
Phase Phase 1
Start date September 2, 2020
Completion date October 18, 2020
View Details
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