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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: MK-0941

• Registration Number: NCT00912002
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-11
• Study Completion: 2009-01
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-03
• Results First Submitted: 2012-04-26
• Results First Submitted QC: 2012-04-26
• Results First Posted: 2012-05-28
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-0941	MK-0941	MK-0941

Primary Outcome Measures

Name	Time	Method
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).	Up to 168 hours after study drug administration	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%.

Secondary Outcome Measures

Name	Time	Method
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