NCT05057949

A Study to Evaluate Drug-Drug Interaction of Larotinib With Itraconazole and Rifampin in Healthy Adult Participants

A Single-center, Open, Self-controlled Design Clinical Study to Evaluate the Pharmacokinetic Effects of Rifampicin or Itraconazole on Single-dose Laolotinib Mesylate Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the effect of rifampin (Part A) and itraconazole(Part B) on the single-dose pharmacokinetics (PK) of Larotinib in healthy adult participants.

Detailed description

The drug being tested in this study is called Larotinib (Z650). The study assessed the drug-drug interaction of Larotinib with either a strong cytochrome P-450 (CYP)3A inducer, rifampin (Part A) , or with a strong CYP3A inhibitor itraconazole (Part B) in healthy adult participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Larotinib	Larotinib Capsules
DRUG	Rifampin	Rifampin Capsules
DRUG	Itraconazole	Itraconazole Capsules

Timeline

• Start date: 2021-11-24
• Primary completion: 2022-02-17
• Completion: 2023-09-28
• First posted: 2021-09-27
• Last updated: 2025-05-18

Locations

1 site across 1 country: China