NCT06332053

A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects

A Randomized, Open-label, Two-period, Self-controlled Study to Evaluate the Effect of Oral Rifampicin or Itraconazole on the Pharmacokinetics of SY-5007 Tablets in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin).

Detailed description

A total of 28 evaluable healthy male subjects will be enrolled in this study. The subjects will be divided into two groups, A and B, with 14 people in each group. In the itraconazole study (Group A), patients received single-dose SY-5007 80 mg on Day 1 and Day 11 and itraconazole 200 mg once or twice daily on Day 8-Day 18 orally. In the rifampicin study (Group B), patients received single-dose SY-5007 160mg on Day 1 and Day 16 and rifampicin 600 mg once daily on Day 8-Day 21 orally.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SY-5007	SY-5007 80 mg, Tablets, 2 discrete single doses at Day 1 and Day 11
DRUG	Itraconazole	Itraconazole 200 mg, Capsules, Day 8-Day 18
DRUG	SY-5007	SY-5007 160 mg, Tablets, 2 discrete single doses at Day 1 and Day 16
DRUG	Rifampin	Rifampin 600 mg, Capsules, Day 8-Day 21

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: China