NCT05902728

Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design. Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	HLX208	Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fed state
DRUG	HLX208	Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fast state.
DRUG	HLX208	450 mg
DRUG	HLX208	900 mg
DRUG	Itraconazole 200 mg	200 mg
DRUG	Rifampicin	600mg

Timeline

• Start date: 2023-07-04
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2023-06-15
• Last updated: 2024-04-05

Locations

1 site across 1 country: China