NCT04322552

A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects

A Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Apatinib Mesylate on Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#, Induces Transporter Pgp function in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on Transporter Pgp function by comparing the pharmacokinetics of Transporter Pgp-specific probe drugs in the presence and absence of Apatinib. The probes used Substrate Digoxin.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate	Apatinib at a dosage of will be administered daily from on D5 through D16
DRUG	Digoxin tablet	Digoxin at a dosage of 0.25mg will be administered at day 1 and day 12

Timeline

• Start date: 2020-03-12
• Primary completion: 2021-04-03
• Completion: 2021-05-03
• First posted: 2020-03-26
• Last updated: 2022-11-07

Locations

1 site across 1 country: China