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

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ClinicalTrials.gov Identifier: NCT00696826
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Liver Insufficiency Drug: sitagliptin phosphate Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2004
Primary Completion Date : May 2004
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs [ Time Frame: throughout study and at 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696826

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00696826     History of Changes
Other Study ID Numbers: 0431-017
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action