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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00696826
First received: June 11, 2008
Last updated: March 7, 2014
Last verified: March 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00696826     History of Changes
Other Study ID Numbers: 0431-017, MK0431-017, 2008_530
Study First Received: June 11, 2008
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014