NCT04843449

Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects

A Phase I, Open Label, Drug-drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ASC40	Oral tablets
DRUG	Itraconazole	Oral capsules
DRUG	rifampicin	Oral capsules

Timeline

• Start date: 2021-04-04
• Primary completion: 2021-05-06
• Completion: 2021-05-14
• First posted: 2021-04-13
• Last updated: 2021-08-23

Locations

1 site across 1 country: China