NCT05528120

Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate pharmacokinetics of a single oral dose of VC004 capsules under fasting and fed conditions in healthy subjects.

Conditions

• Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Interventions

Type	Name	Description
DRUG	VC004 Capsules	Oral administration after fasting/high-fat meal
DRUG	VC004 Capsules	Oral administration after high-fat/fasting meal

Timeline

• Start date: 2022-10-20
• Primary completion: 2022-10-28
• Completion: 2022-11-23
• First posted: 2022-09-06
• Last updated: 2022-11-30

Locations

1 site across 1 country: China