NCT07438886

Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers

A Non-Randomized, Open-Label Clinical Study of Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) With Itraconazole and Ticagrelor in Healthy Volunteer Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Advenchen Laboratories Nanjing Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a non-randomized, open-label, fixed-sequence drug-drug interaction study to evaluate the effects of itraconazole and ticagrelor on the pharmacokinetics of catequentinib hydrochloride (AL3818) in healthy volunteers.

Detailed description

This is a non-randomized, open-label, single-center, fixed-sequence drug-drug interaction (DDI) study to evaluate the effects of itraconazole and ticagrelor on the pharmacokinetics of catequentinib hydrochloride (AL3818) in healthy adult subjects. Eligible subjects will receive a single dose of AL3818 alone and in combination with multiple doses of itraconazole or ticagrelor in different periods. Serial blood samples will be collected to determine plasma concentrations of AL3818. Safety and tolerability will be monitored throughout the study.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	AL3818 Capsule	dosage form: capsule; strength: 8 mg; orally in fasted condition
DRUG	Itraconazole capsule	dosage form: capsule; strength: 0.1 g. Oral
DRUG	Ticagrelor Tablets	dosage form: tablet; strength: 90 mg.Oral

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China