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NCT01002378 Clinical Trial

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

Pharmacokinetics Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01002378
Other study ID # 14656
Secondary ID
Status Completed
Phase Phase 1
First received October 26, 2009
Last updated May 21, 2013
Start date October 2009
Est. completion date February 2010

Study information
Verified date May 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
A single dose of regorafenib will be administered immediately following a high fat breakfast
• Regorafenib (Stivarga, BAY73-4506)
A single dose of regorafenib will be administered immediately following a low fat breakfast
• Regorafenib (Stivarga, BAY73-4506)
A single dose of regorafenib will be administered following an overnight fast

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary PK parameters: AUC, Cmax of BAY 73-4506 Samples up to 336 hours post dose No
Secondary Sec. PK Parameters: tmax and t1/2 of BAY73-4506 Samples up to 336 hours post dose No
Secondary AUC, Cmax, tmax and t1/2 of Metabolites Samples up to 336 hours post dose No
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