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The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib

NCT01002378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-05-23

No results posted yet for this study

Summary

An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.

Conditions

  • Dietary Fats
  • Pharmacokinetics

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

A single dose of regorafenib will be administered immediately following a high fat breakfast

DRUG

Regorafenib (Stivarga, BAY73-4506)

A single dose of regorafenib will be administered immediately following a low fat breakfast

DRUG

Regorafenib (Stivarga, BAY73-4506)

A single dose of regorafenib will be administered following an overnight fast

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01002378 on ClinicalTrials.gov