Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

Key facts

Study ID

NCT01318265

Run by

Bayer

People needed

24

Starts

2011-03-01

Expected to finish

2011-07-01

Last updated by the study team

2014-11-03

Who can join

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

You may qualify if…

• Healthy male subjects between 18 and 45 years of age, inclusive
• BMI between 18 and 32 kg/m2 inclusive

You may not qualify if…

• Subjects with evidence of disease, conditions affecting drug absorption or metabolism
• Treatment with other investigational drug within 30 days
• History of regular alcohol or recreational drug consumption
• Use of prescription drugs within 14 days
• Use of nonprescription drugs and dietary supplement within 7 days
• Blood donation within 30 days

Where it is running

• Study site — Brighton, Massachusetts, United States

Full record on ClinicalTrials.gov

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