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

Liver Insufficiency Clinical Trial

Official title:

An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696826
• Other study ID #: 0431-017
• Secondary ID: MK0431-0172008_5
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2008
• Last updated: August 18, 2015
• Start date: April 2004
• Est. completion date: May 2004

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs		throughout study and at 12 weeks	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site