NCT04649723

Drug-Drug Interaction of SHR1459 With a Strong CYP3A Index Inducer (Rifampicin)

A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Phase I Drug-Drug Interaction Clinical Study of the Effect of Rifampicin on Pharmacokinetics of SHR1459 in Chinese Healthy Subjects.

• Status: Completed
• 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 strong CYP 3A index fan-inducer rifampicin on the pharmacokinetics of SHR1459 in Chinese healthy volunteers.

Conditions

• Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459

Interventions

Type	Name	Description
DRUG	Rifampin	single oral dose, 600 mg, fasted.
DRUG	SHR1459	single oral dose, 200 mg, fasted.

Timeline

• Start date: 2020-11-24
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2020-12-02
• Last updated: 2021-01-11

Locations

1 site across 1 country: China