NCT07341672

A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants

The Drug-Drug Interaction Study of Clifutinib

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib and the safety of the combination therapy in healthy participants.

Conditions

• Healthy Adult Subject

Interventions

Type	Name	Description
DRUG	Clifutinib	The subjects are required to take Clifutinib on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.
DRUG	Itraconazole	Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch.
DRUG	fluconazole	Take fluconazole on an empty stomach
DRUG	efavirenz	Take efavirenz on an empty stomach

Timeline

• Start date: 2026-03-04
• Primary completion: 2026-04-23
• Completion: 2026-05-08
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: China