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A Study of MK0431 in Patients WIth Hepatic Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00696826
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013