NCT00696826

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

June 11, 2008

Last Update Submit

August 18, 2015

Conditions

Liver Insufficiency

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    throughout study and at 12 weeks

Interventions

sitagliptin phosphateDRUG

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

Also known as: MK0431

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • If female, non pregnant, BMI less than 40 kg/m2
  • Patient has chronic, stable hepatic insufficiency

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 19221403RESULT

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

April 1, 2004

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

August 19, 2015

Record last verified: 2015-08