A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)
Phase 1
Completed
- Conditions
- Liver Insufficiency
- Registration Number
- NCT00696826
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- If female, non pregnant, BMI less than 40 kg/m2
- Patient has chronic, stable hepatic insufficiency
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Exclusion Criteria
- Patient unwilling to refrain from alcohol and grapefruit juice prior to and shortly after study drug administration
- Patient has diabetes, had a heart attack or stroke, or uncontrolled congestive heart failure during the past 6 months
- Patient has a history of drug or alcohol abuse
- Patient smokes > 10 cigarettes per day
- Patient consumes more that 6 cups of caffeinated beverages per day
- Patient has had surgery, donated blood or participated in another clinical trial within the past 4 weeks
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method the plasma and urine pharmacokinetic parameters of MK0431 measured at predose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 18, 24, 32, 48, 72 and 96 hours post dose
- Secondary Outcome Measures
Name Time Method Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs throughout study and at 12 weeks