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

NCT ID: NCT01002378

Last Updated: 2013-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Dietary Fats Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

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

Arm 2

Group Type EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

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

Arm 3

Group Type EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

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

Interventions

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Regorafenib (Stivarga, BAY73-4506)

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

Intervention Type DRUG

Regorafenib (Stivarga, BAY73-4506)

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

Intervention Type DRUG

Regorafenib (Stivarga, BAY73-4506)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare Pharmaceuticals Inc

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Brighton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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14656

Identifier Type: -

Identifier Source: org_study_id

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