NCT05368805

Fruquintinib DDI Study With P-gp and BCRP Substrates

A Phase 1, Open-label, 2-part, 2-period Fixed-sequence Study to Evaluate the Effect of Fruquintinib on the Pharmacokinetics of Dabigatran Etexilate (A P-GP Substrate) and Rosuvastatin (A BCRP Substrate) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Fruquintinib DDI Study with P-gp and BCRP Substrates

Detailed description

A phase 1, open-label, 2-part, 2-period fixed-sequence study to evaluate the effect of Fruquintinib on the pharmacokinetics of Dabigatran Etexilate (A P-GP substrate) and Rosuvastatin (A BCRP substrate) in healthy subjects

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib will be administered as a single oral 5mg dose on the morning of day 5
DRUG	Dabigatran Etexilate	Dabigatran Etexilate will be administered as a single oral dose 150mg on the morning of day 1 and morning of day 5
DRUG	Rosuvastatin	Rosuvastatin will be administered as a single oral dose 10mg on the morning of day 1 and the morning of day 5

Timeline

• Start date: 2022-03-02
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2022-05-10
• Last updated: 2022-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study