check_circleStudy Completed

Dietary Fats, Pharmacokinetics

Bayer Identifier:

14656

ClinicalTrials.gov Identifier:

NCT01002378

EudraCT Number:

Not Available

EU CT Number:

Not Available
The effect of food (high fat and low fat breakfast) on the pharmacokinetics of regorafenib

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

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

Trial summary

Enrollment Goal
24
Trial Dates
October 2009 - February 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
ProMedica Clincal Research CenterBrighton, 02135, United States

Primary Outcome

  • Primary PK parameters: AUC, Cmax of BAY 73-4506
    date_rangeTime Frame:
    Samples up to 336 hours post dose
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Sec. PK Parameters: tmax and t1/2 of BAY73-4506
    date_rangeTime Frame:
    Samples up to 336 hours post dose
    enhanced_encryption
    Safety Issue:
    no
  • AUC, Cmax, tmax and t1/2 of Metabolites
    date_rangeTime Frame:
    Samples up to 336 hours post dose
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Screening
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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