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OpenTrials
Completed

NCT Number: NCT01002378

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

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.

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Key information

Conditions

Dietary Fats Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Brighton, Massachusetts, 02135, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regorafenib (Stivarga, BAY73-4506)

Drug

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

Primary outcomes

  1. Primary PK parameters: AUC, Cmax of BAY 73-4506

    Time frame: Samples up to 336 hours post dose

Secondary outcomes

  1. Sec. PK Parameters: tmax and t1/2 of BAY73-4506

    Time frame: Samples up to 336 hours post dose

  2. AUC, Cmax, tmax and t1/2 of Metabolites

    Time frame: Samples up to 336 hours post dose

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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