NCT05383131

To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers

A Single Center, Open Label Study to Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or Nintedanib in healthy volunteers

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	HEC585	Mulltiple doses of HEC585 for up to 10 days
DRUG	Pirfenidone	Mulltiple doses of Pirfenidone for up to 3 days
DRUG	Nintedanib	Mulltiple doses of Nintedanib for up to 7 days

Timeline

• Start date: 2021-06-23
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2022-05-19
• Last updated: 2022-05-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study