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

A Study to Investigate the Absorption, Metabolism, Excretion and Mass Balance After Administration of a Single Dose of [14C]MK-0941

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: MK-0941

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-0941	Drug: MK-0941; A single dose of 40 mg of [14C]MK-0941 (160 µCi), taken orally as eight 5-mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).	Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.	Up to 168 hours after study drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Experienced An Adverse Event	Up to 14 days after study drug administration
Number of Participants Who Discontinued the Study Due to An Adverse Event	Up to 14 days after study drug administration

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 1, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 0941-016; 2008_598 (Merck Study Number)