NCT07535970

A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.

Detailed description

On Day 1 and Day 11 of the trial, HS-10506 tablets will be orally administered under fasting conditions in the morning. From Day 7 to Day 15, itraconazole capsules (0.2 g, administered as two 0.1 g capsules) will be taken orally once daily for nine consecutive days. On the morning of Day 11, itraconazole capsules and HS-10506 tablets will be taken concurrently. When administered alone or in combination with itraconazole capsules, HS-10506 tablets will be given under fasting conditions. When administered alone, itraconazole capsules will be taken within 15 minutes after a meal, with approximately 240 mL of water.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	HS-10506, Itraconazole	HS-10506: Administered under fasting conditions in the morning. Itraconazole: Itraconazole capsules (0.2 g) are taken orally once daily for nine consecutive days.

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China