A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: MK-0941

Study type

Interventional

Funder types

Industry

Identifiers

NCT00912002

0941-016

2008_598 (Other Identifier)

Details and patient eligibility

About

A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantities of 14C-labeled MK-0941.

Enrollment

6 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has been diagnosed with type 2 diabetes, and is being treated with diet and exercise or with an oral anti-hyperglycemic agent
Subject is willing to follow the American Heart Association diet and exercise program throughout the study
Subject is a nonsmoker and/or has not used nicotine products for at least 6 months

Exclusion criteria

Subject has a history of stroke, seizures, or major neurological disorder
Subject has a history of neoplastic disease
Subject has recently had abnormal bowel habits, such as diarrhea, loose stools or constipation
Subject has a history of type 1 diabetes mellitus
Subject has received insulin within the past 12 weeks
Subject has a recent history of eye infection
Subject has been diagnosed with glaucoma or is blind
Subject consumes more than 3 alcoholic beverages per day
Subject consumes more than 6 servings of coffee, tea, cola per day
Subject has had major surgery, donated or lost blood in the past 4 weeks
Subject has multiple or severe allergies to any food or drugs