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

• ClinicalTrials.gov Identifier: NCT00912002
• Recruitment Status: Completed
• First Posted: June 3, 2009
• Results First Posted: May 28, 2012
• Last Update Posted: July 3, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: June 1, 2009
• First Posted Date: June 3, 2009
• Results First Submitted Date: April 26, 2012
• Results First Posted Date: May 28, 2012
• Last Update Posted Date: July 3, 2015
• Study Start Date: October 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2012)

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 ]

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%.

• Original Primary Outcome Measures (submitted: June 1, 2009): determine the routes of elimination and mass balance of MK0941 after a single dose oral administration [ Time Frame: blood, urine, and fecal samples taken 0.5-168 hours post drug administration ]

Current Secondary Outcome Measures (submitted: April 26, 2012)

• Number of Participants Who Experienced An Adverse Event [ Time Frame: Up to 14 days after study drug administration ]
• Number of Participants Who Discontinued the Study Due to An Adverse Event [ Time Frame: Up to 14 days after study drug administration ]

• Original Secondary Outcome Measures (submitted: June 1, 2009): evaluate the safety and tolerability of MK0941 [ Time Frame: 10-14 days post drug administration ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
• Official Title: A Study to Investigate the Absorption, Metabolism, Excretion and Mass Balance After Administration of a Single Dose of [14C]MK-0941
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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

Study Arms

Experimental: MK-0941

MK-0941

Intervention: Drug: MK-0941

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 1, 2009): 6
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00912002
• Other Study ID Numbers: 0941-016; 2008_598
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: June 2015