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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

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