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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912002
• Other study ID #: 0941-016
• Secondary ID: 2008_598
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2009
• Last updated: June 8, 2015
• Start date: October 2008
• Est. completion date: January 2009

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• MK-0941
A single dose of 40 mg of [14C]MK-0941 (160 µCi), taken orally as eight 5-mg capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants Who Experienced An Adverse Event		Up to 14 days after study drug administration	Yes
Secondary	Number of Participants Who Discontinued the Study Due to An Adverse Event		Up to 14 days after study drug administration	Yes