NCT04557397

Fruquintinib CYP3A Inhibitor and Inducer Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	Fruquintinib	oral VEGFR inhibitor
DRUG	Itraconazole	a synthetic triazole antifungal agent
DRUG	Rifampin	a semisynthetic antibiotic derivative of rifamycin SV

Timeline

• Start date: 2020-09-02
• Primary completion: 2020-10-18
• Completion: 2020-10-18
• First posted: 2020-09-21
• Last updated: 2021-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study