Liver Insufficiency
Conditions
Brief summary
A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.
Interventions
DRUGsitagliptin phosphate
sitagliptin phosphate 100 mg MK0431 (2 x 50 mg tablets) taken orally after overnight fast; Duration of Treatment: 5 Weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* If female, non pregnant, BMI less than 40 kg/m2 * Patient has chronic, stable hepatic insufficiency
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs | throughout study and at 12 weeks |
Outcome results
None listed