Effect of Ketoconazole on the Pharmacokinetics of Refametinib

Completed · Phase 1

Conditions studied: Drug Interactions

In brief

The purpose of this study is to see if there is a difference between the way your body absorbs and distributes BAY86-9766 when given alone or in combination with ketoconazole, a drug which may affect how much BAY86-9766 is absorbed, distributed or eliminated from the body

Key facts

Study ID

NCT01925638

Run by

Bayer

People needed

18

Starts

2013-09-01

Expected to finish

2013-12-01

Last updated by the study team

2014-01-08

Who can join

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

You may qualify if…

• Healthy male subject
• Age: 18 to 45 years (inclusive) at the first screening examination / visit
• Body mass index (BMI): 18.5 to 32 kg/m² (inclusive)
• Ability to understand and follow study-related instructions. Subject, who is a sexually active man and has not been surgically sterilized, must consent that he uses a condom during intercourse and ensures that his female partner practices adequate contraception, or he must be willing to refrain from sexual intercourse from the beginning of the trial (signing of the informed consent) until 30 days after last study drug administration

You may not qualify if…

• Clinically significant disease or condition
• Retinal pathology or vien occlusion
• Left Ventricular ejection Fraction(LVEF) <60% (as measured at screening) by Multiple Gated Acquisition Scan(MUGA) or echocardiogram

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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