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

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ClinicalTrials.gov Identifier: NCT01002378
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : May 23, 2013
Sponsor:
Information provided by:
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Dietary Fats Pharmacokinetics Drug: Regorafenib (Stivarga, BAY73-4506) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

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

Experimental: Arm 2 Drug: Regorafenib (Stivarga, BAY73-4506)
A single dose of regorafenib will be administered immediately following a low fat breakfast

Experimental: Arm 3 Drug: Regorafenib (Stivarga, BAY73-4506)
A single dose of regorafenib will be administered following an overnight fast




Primary Outcome Measures :
  1. Primary PK parameters: AUC, Cmax of BAY 73-4506 [ Time Frame: Samples up to 336 hours post dose ]

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


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002378


Locations
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United States, Massachusetts
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01002378     History of Changes
Other Study ID Numbers: 14656
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013