A Single-Dose Investigational Drug Probe Formulation and Food Effect Study in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00567112

Purpose

A study to compare the PK of the capsule and tablet formulations of an investigational drug and to assess the effect of food on the tablet formulation.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK0941	Phase I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-availability Study
Official Title:	An Open-Label, Randomized, Partially Fixed-Sequence, 3-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK0941 in Patients With Type 2 Diabetes

Further study details as provided by Merck:

Primary Outcome Measures:

Pharmacokinetics of the capsule formulation compared to the tablet formulation. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The effect of food on the pharmacokinetics of the tablet formulation. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	November 2007
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

This study will include 3 sequences testing 2 possible formulations. A = 10 mg DFC formulation of MK0941 (Phase I formulation) fasted; B = 10 mg OCT formulation of MK0941 (Phase II formulation) fasted; C = 10 mg OCT formulation of MK0941 after consumption of a high-fat meal. over 8 Weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female (of non-childbearing potential) between the ages of 18 to 70
Subjects have been diagnosed with Type 2 Diabetes
Subjects are nonsmokers for at least 6 months

Exclusion Criteria:

Subjects should not be diagnosed with Type 1 diabetes
Subjects should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
Subject has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
Subject has been diagnosed with glaucoma or is blind
Subject has had trauma to one or both eyes
Subject has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
Subject is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567112

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_652, MK0941-009
Study First Received:	November 30, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00567112
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009