A Study of MK0431 in Patients WIth Hepatic Insufficiency - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00696826

Purpose

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

Condition	Intervention	Phase
Liver Insufficiency	Drug: sitagliptin phosphate	Phase I

Drug Information available for: Sitagliptin phosphate Sitagliptin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs [ Time Frame: throughout study and at 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	April 2004
Study Completion Date:	May 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696826

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_530, MK0431-017
Study First Received:	June 11, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00696826
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Sitagliptin
Hepatic Insufficiency

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009