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

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Bayer

Status and phase

Completed
Phase 1

Conditions

Dietary Fats
Pharmacokinetics

Treatments

Drug: Regorafenib (Stivarga, BAY73-4506)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 3 patient groups

Arm 1
Experimental group
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Regorafenib (Stivarga, BAY73-4506)
Arm 2
Experimental group
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Regorafenib (Stivarga, BAY73-4506)
Arm 3
Experimental group
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Regorafenib (Stivarga, BAY73-4506)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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