A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
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 Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study to Investigate the Absorption, Metabolism, Excretion and Mass Balance After Administration of a Single Dose of [14C]MK-0941|
- Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi). [ Time Frame: Up to 168 hours after study drug administration ] [ Designated as safety issue: No ]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%.
- Number of Participants Who Experienced An Adverse Event [ Time Frame: Up to 14 days after study drug administration ] [ Designated as safety issue: Yes ]
- Number of Participants Who Discontinued the Study Due to An Adverse Event [ Time Frame: Up to 14 days after study drug administration ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
A single dose of 40 mg of [14C]MK-0941 (160 µCi), taken orally as eight 5-mg capsules
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912002
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|