Trial Condition(s):

Drug interactions

Effect of ketoconazole on the pharmacokinetics of refametinib

Bayer Identifier:

14751

ClinicalTrials.gov Identifier:

NCT01925638

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
18
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Pharmaceutical Product Development, LLC

Austin, United States, 78744

Status
Active, not recruiting
 

Trial Design