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

NCT ID: NCT00912002

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-01-31

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-0941

MK-0941

Group Type: EXPERIMENTAL

MK-0941

Intervention Type: DRUG

A single dose of 40 mg of \[14C\]MK-0941 (160 µCi), taken orally as eight 5-mg capsules

Interventions

MK-0941

A single dose of 40 mg of \[14C\]MK-0941 (160 µCi), taken orally as eight 5-mg capsules

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2008_598

Identifier Type: -

Identifier Source: secondary_id

0941-016

Identifier Type: -

Identifier Source: org_study_id