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

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

Completed

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Key information

Conditions

Liver Insufficiency Digestive System Diseases Hepatic Insufficiency Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin phosphate

Drug

sitagliptin phosphate 100 mg MK0431 (2 x 50 mg tablets) taken orally after overnight fast; Duration of Treatment: 5 Weeks

Other names: MK0431

Primary outcomes

the plasma and urine pharmacokinetic parameters of MK0431

Time frame: 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 outcomes

Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs

Time frame: throughout study and at 12 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Jun 13, 2008
Registry last updated: Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed