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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: MK-0941


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 |