check_circleStudy Completed

Drug interactions

Bayer Identifier:

14751

ClinicalTrials.gov Identifier:

NCT01925638

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effect of ketoconazole on the pharmacokinetics of refametinib

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - 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
  • - 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
September 2013 - December 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Active, not recruiting
Pharmaceutical Product Development, LLCAustin, 78744, United States

Primary Outcome

  • Cmax(maximum observed drug concentration in measured matrix after single dose administration) of BAY86-9766
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(area under the concentration vs. time curve from zero to infinity after single (first) dose) of BAY86-9766
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t1/2(half-life associated with the terminal slope) of BAY86-9766
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    2.5 months
    enhanced_encryption
    Safety Issue:
    Yes
  • AUC(0-tlast)(AUC from time 0 to the last data point > LLOQ) of BAY86-9766 and Metabolites M-11 and M-17
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax(time to reach Cmax) of BAY86-9766 and Metabolites M-11 and M-17
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tlast(time of last observed concentration value above lower limit of quantitation) of BAY86-9766 and Metabolites M-11 and M-17
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax(maximum observed drug concentration in measured matrix after single dose administration) of Metabolites M-11 and M-17
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(area under the concentration vs. time curve from zero to infinity after single (first) dose) of Metabolites M-11 and M-17
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t1/2(half-life associated with the terminal slope) of Metabolites M-11 and M-17
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • CL/F(total body clearance of drug calculated after extravascular administration) of BAY 86-9766)
    date_rangeTime Frame:
    Day 1: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h post-dose; Day 8: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label study in healthy male subjects to assess the effect of a strong CYP3A4 inhibitor, ketoconazole, on the pharmacokinetics of refametinib
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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