A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Liver Insufficiency

Treatments: Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696826

MK0431-017

2008_530

0431-017

Details and patient eligibility

About

A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)