A Single Dose Study to Investigate the Pharmacokinetics of MK0941 in Subjects With Renal Insufficiency


Tracking Information

Start Date  ICMJEJanuary 2009
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 26, 2009)		plasma pharmacokinetics of MK0941 after administration of a single 20-mg dose of MK0941 to subjects with Type 2 diabetes and varying degrees of renal insufficiency [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00830791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 26, 2009)		urinary pharmacokinetics of MK0941 after administration of a single 20-mg dose of MK0941 to subjects with Type 2 diabetes and varying degrees of renal insufficiency [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Single Dose Study to Investigate the Pharmacokinetics of MK0941 in Subjects With Renal Insufficiency
Official Title  ICMJEA Single Dose Study to Investigate the Pharmacokinetics of MK0941 in Subjects With Renal Insufficiency
Brief Summary

This study will assess the pharmacokinetics of MK0941 in subjects with varying degrees of renal insufficiency.

Detailed Description 
Study PhasePhase I
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Condition  ICMJEType 2 Diabetes
Intervention  ICMJEDrug: MK0941
A single 20-mg dose tablet of MK0941.
Study Arms / Comparison GroupsMK0941: Experimental
MK0941
Intervention: Drug: MK0941

Recruitment Information

Estimated Enrollment  ICMJE48
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or nonpregnant female age 18 to 75 years
  • Female of childbearing potential on appropriate method of contraception
  • BMI less than or equal to 40 kg/m2 --subject is in good health
  • Subject diagnosed with Type 2 Diabetes
  • Clinical diagnosis of renal insufficiency
  • Subject agrees to follow smoking restrictions
  • Willing to follow the study diet restrictions

Exclusion Criteria:

  • Mental or legal incapacitation
  • Subject has had kidney removed
  • History of Type 1 diabetes
  • History of stroke, chronic seizures or major neurological disorder
  • History of neoplastic disease
  • Nursing mother
  • Consumes greater than 4 glasses of alcoholic beverages per day
  • Consumes greater than 6 servings of caffeinated beverages per day
  • Subject has had surgery or donated 1 unit of blood within 1 month of screening
  • Subject has history of recent eye infection within 2 weeks of study drug administration
  • Clinically diagnosed with glaucoma or blindness
  • Has trauma to one or both eyes
GenderBoth
Ages18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00830791
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2009_522, MK0941-015
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck