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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002378

Enrollment

Registered

2009-10-27

Start date

2009-10-31

Completion date

2010-02-28

Last updated

2013-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Fats, Pharmacokinetics

Brief 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.

Interventions

DRUGRegorafenib (Stivarga, BAY73-4506)

A single dose of regorafenib will be administered immediately following a high fat breakfast

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Primary PK parameters: AUC, Cmax of BAY 73-4506	Samples up to 336 hours post dose

Secondary

Measure	Time frame
Sec. PK Parameters: tmax and t1/2 of BAY73-4506	Samples up to 336 hours post dose
AUC, Cmax, tmax and t1/2 of Metabolites	Samples up to 336 hours post dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026