An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431
Sponsor study identifier
Secondary identifiers
interventional
20
0 countries
N/A
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2004
Actual (reported)Study Completion
May 2004
Actual (reported)A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2004
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
May 2004
Actual (reported)May 2004
Actual (reported)June 11, 2008
Actual (reported)June 13, 2008
Actual (reported)the plasma and urine pharmacokinetic parameters of MK0431
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
Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs
throughout study and at 12 weeks
sitagliptin phosphate 100 mg MK0431 (2 x 50 mg tablets) taken orally after overnight fast; Duration of Treatment: 5 Weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Migoya EM, Stevens CH, Bergman AJ, Luo WL, Lasseter KC, Dilzer SC, Davies MJ, Wagner JA, Herman GA. Effect of moderate hepatic insufficiency on the pharmacokinetics of sitagliptin. Can J Clin Pharmacol. 2009 Winter;16(1):e165-70. Epub 2009 Feb 16.
Medical Monitor
Merck Sharp & Dohme LLC
20 participants (actual enrollment reported by the registry).
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2004
Actual (reported)Study Completion
May 2004
Actual (reported)Last Updated
August 19, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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