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

Bayer

Status and phase: Completed; Phase 1

Conditions: Dietary Fats; Pharmacokinetics

Treatments: Drug: Regorafenib (Stivarga, BAY73-4506)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002378

14656

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)

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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)