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

NCT ID: NCT00696826

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2004-05-31

Brief Summary

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

Conditions

Liver Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sitagliptin phosphate

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

Intervention Type: DRUG

Other Intervention Names

MK0431

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 19221403 (View on PubMed)

Other Identifiers

MK0431-017

Identifier Type: -

Identifier Source: secondary_id

2008_530

Identifier Type: -

Identifier Source: secondary_id

0431-017

Identifier Type: -

Identifier Source: org_study_id