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

Completed · Phase 1

Conditions studied: Dietary Fats, Pharmacokinetics

In brief

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 facts

Study ID

NCT01002378

Run by

Bayer

People needed

24

Starts

2009-10-01

Expected to finish

2010-02-01

Last updated by the study team

2013-05-23

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Study site — Brighton, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.