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

Primary Purpose

Liver Insufficiency

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

sitagliptin phosphate

About this trial

This is an interventional treatment trial for Liver Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

the plasma and urine pharmacokinetic parameters of MK0431

Secondary Outcome Measures

Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs

Full Information

NCT ID

NCT00696826

First Posted

June 11, 2008

Last Updated

August 18, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00696826

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

May 2004 (Actual)

Study Completion Date

May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

sitagliptin phosphate

Other Intervention Name(s)

MK0431

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs

Time Frame

throughout study and at 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

19221403

Citation

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.

Results Reference

result

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

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