NCT04680091

Drug-Drug Interaction of Pyrotinib With a Moderate CYP3A Inducer

A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Phase I Drug-Drug Interaction Clinical Study of the Effect of Efavirenz on Pharmacokinetics of Maleate Pyrotinib in Chinese Healthy Subjects.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This drug-drug interaction (DDI) study had been designed to investigate the effect of a moderate CYP 3A inducer efavirenz on the pharmacokinetics of maleate pyrotinib in Chinese healthy volunteers.

Conditions

• Healthy Subjects, Drug-drug Interaction, Pyrotinib

Interventions

Type	Name	Description
DRUG	Pyrotinib Maleate	single oral dose, 400 mg, fed.
DRUG	Efavirenz	single oral dose, 600 mg, fasted, at bedtime.

Timeline

• Start date: 2020-11-12
• Primary completion: 2021-01-28
• Completion: 2021-12-30
• First posted: 2020-12-22
• Last updated: 2021-04-22

Locations

1 site across 1 country: China