NCT06325761

A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects

A Randomized, Open-label, Single-dose, Two-period, Two-treatment Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of SY-5007 Tablets in Chinese Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.

Detailed description

The study consists of two parts: a pilot study and a formal study. The pilot study involves four healthy subjects who will receive a single dose of SY-5007 80 mg after a meal (high-fat meal) for Period 1 and on an empty stomach for Period 2, with observation and PK blood sample collection. The formal study plans to enroll 24 healthy subjects, divided into Groups A and B, each with 12 subjects, receiving a dose of 160 mg. Group A will receive the drug on an empty stomach for Period 1, followed by administration after a meal (high-fat meal) for Period 2, while Group B will follow the reverse sequence. Both groups will adopt a two-period, two-treatment crossover design with a washout period of 7 days. If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007, subsequent trial protocols may be adjusted.

Conditions

• Health Subjects

Interventions

Type	Name	Description
DRUG	SY-5007	SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days
DRUG	SY-5007	SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

1 site across 1 country: China