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

This study is currently recruiting participants.

Verified by Merck, April 2009

First Received: January 26, 2009 Last Updated: April 1, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00830791

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes	Drug: MK0941	Phase I

MedlinePlus related topics: Diabetes

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Single Dose Study to Investigate the Pharmacokinetics of MK0941 in Subjects With Renal Insufficiency

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	48
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MK0941: Experimental MK0941	Drug: MK0941 A single 20-mg dose tablet of MK0941.

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830791

Locations

Russian Federation
Merck Sharp & Dohme IDEA, Inc.	Recruiting
Moscow, Russian Federation, 121059
Contact: Tatiana Serebriakova 7-495-941-8264

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_522, MK0941-015
Study First Received:	January 26, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00830791 History of Changes
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009