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

May 21, 2013 updated by: Bayer

A Phase I, Randomized, Open Label, 3-Way Cross-Over Study to Determine the Effect of a High-Fat Breakfast, a Low-Fat Breakfast and Fasting State on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subject
  • Age: 18 to 45 years (inclusive) at the first Screening examination
  • BMI: between 18 and 32 kg / m²

Exclusion Criteria:

  • Regular use of medicines at the time of Screening, including prescription medications, herbal supplements and high dose vitamins
  • Sitting systolic BP > 140 mmHg or Diastolic BP > 90 or < 60 mmHg
  • History of hypersensitivity or allergy
  • History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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
Experimental: Arm 2
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
Experimental: Arm 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary PK parameters: AUC, Cmax of BAY 73-4506
Time Frame: Samples up to 336 hours post dose
Samples up to 336 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Sec. PK Parameters: tmax and t1/2 of BAY73-4506
Time Frame: Samples up to 336 hours post dose
Samples up to 336 hours post dose
AUC, Cmax, tmax and t1/2 of Metabolites
Time Frame: Samples up to 336 hours post dose
Samples up to 336 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 14656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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