Phase 1
Completed N=6
A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
Source: ClinicalTrials.gov NCT00912002 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi). — 60.0; 38.7 Percent Recovered
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi). |
60.0; 38.7 | — |
| SECONDARY Number of Participants Who Experienced An Adverse Event |
5 | — |
| SECONDARY Number of Participants Who Discontinued the Study Due to An Adverse Event |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00912002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.