Study 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

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

Trial Dates

September 2013 - December 2013

Phase

Phase 1

Could I Receive a placebo

Products

Refametinib (BAY86-9766)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Active, not recruiting	Pharmaceutical Product Development, LLC	Austin, 78744, United States

Primary Outcome

Cmax(maximum observed drug concentration in measured matrix after single dose administration) of BAY86-9766
Time 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
Safety Issue:
No
AUC(area under the concentration vs. time curve from zero to infinity after single (first) dose) of BAY86-9766
Time 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
Safety Issue:
No
t1/2(half-life associated with the terminal slope) of BAY86-9766
Time 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
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
2.5 months
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
Time 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
Safety Issue:
No
tmax(time to reach Cmax) of BAY86-9766 and Metabolites M-11 and M-17
Time 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
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
Time 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
Safety Issue:
No
Cmax(maximum observed drug concentration in measured matrix after single dose administration) of Metabolites M-11 and M-17
Time 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
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
Time 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
Safety Issue:
No
t1/2(half-life associated with the terminal slope) of Metabolites M-11 and M-17
Time 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
Safety Issue:
No
CL/F(total body clearance of drug calculated after extravascular administration) of BAY 86-9766)
Time 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
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

Additional Information

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