MedTrace Logo

Fruquintinib Food Effect and Proton Pump Inhibitor Study

NCT04645940 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-06-18

No results posted yet for this study

Summary

The purpose of this is to evaluate the effect of food and the effect of a proton pump inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib.

Conditions

  • Drug Interaction
  • Food-drug Interaction

Interventions

DRUG

fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazole

fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15. 40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.

DRUG

fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole

fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15. 40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Youngiun Kim, MD · WCCT Global Inc

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2020-11-18
Completion
2020-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04645940 on ClinicalTrials.gov