NCT07229560

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants

The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	HRS-8080 Tablet	HRS-8080 tablet, specified dose on specified days.
DRUG	Itraconazole Capsule	Itraconazole capsule, specified dose on specified days.

Timeline

• Start date: 2025-11-26
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-11-17
• Last updated: 2026-01-14

Locations

1 site across 1 country: China