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

An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431

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

Study Overview

• Status: Completed
• Conditions: Liver Insufficiency
• Intervention / Treatment: Drug: sitagliptin phosphate

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs	throughout study and at 12 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Migoya EM, Stevens CH, Bergman AJ, Luo WL, Lasseter KC, Dilzer SC, Davies MJ, Wagner JA, Herman GA. Effect of moderate hepatic insufficiency on the pharmacokinetics of sitagliptin. Can J Clin Pharmacol. 2009 Winter;16(1):e165-70. Epub 2009 Feb 16.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (Estimate): June 13, 2008

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 0431-017; MK0431-017; 2008_530