NCT04459598

A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants

An Open-label, Parallel Drug Interaction Study to Evaluate the Effect of a CYP3A Moderate Inducer Efavirenz on the Pharmacokinetics of Quizartinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This drug-drug interaction (DDI) study has been designed to investigate the effect of a moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major circulating active metabolite AC886.

Detailed description

In vitro, quizartinib is metabolized primarily by CYP3A. Therefore, co-administration of quizartinib with CYP3A inducers may decrease quizartinib exposure. This study will assess the effect of a moderate CYP3A inducer efavirenz on the single dose (60 mg) quizartinib pharmacokinetics in healthy participants.

Conditions

• Healthy Subjects
• Drug-drug Interaction
• Pharmacokinetics
• Quizartinib

Interventions

Type	Name	Description
DRUG	Efavirenz	Single oral dose, 600-mg tablet
DRUG	Quizartinib	Single oral dose, 60 mg (2 x 30 mg) tablets

Timeline

• Start date: 2020-08-19
• Primary completion: 2020-10-14
• Completion: 2020-10-14
• First posted: 2020-07-07
• Last updated: 2022-06-28
• Results posted: 2022-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study