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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01002378
First received: October 26, 2009
Last updated: May 21, 2013
Last verified: May 2013

October 26, 2009
May 21, 2013
October 2009
February 2010   (final data collection date for primary outcome measure)
Primary PK parameters: AUC, Cmax of BAY 73-4506 [ Time Frame: Samples up to 336 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01002378 on ClinicalTrials.gov Archive Site
  • Sec. PK Parameters: tmax and t1/2 of BAY73-4506 [ Time Frame: Samples up to 336 hours post dose ] [ Designated as safety issue: No ]
  • AUC, Cmax, tmax and t1/2 of Metabolites [ Time Frame: Samples up to 336 hours post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
  • Dietary Fats
  • Pharmacokinetics
  • 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 1
    Intervention: Drug: Regorafenib (Stivarga, BAY73-4506)
  • Experimental: Arm 2
    Intervention: Drug: Regorafenib (Stivarga, BAY73-4506)
  • Experimental: Arm 3
    Intervention: Drug: Regorafenib (Stivarga, BAY73-4506)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01002378
14656
No
Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP