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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE June 1, 2009
First Posted Date  ICMJE June 3, 2009
Results First Submitted Date  ICMJE April 26, 2012
Results First Posted Date  ICMJE May 28, 2012
Last Update Posted Date July 3, 2015
Study Start Date  ICMJE October 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Drug: MK-0941
A single dose of 40 mg of [14C]MK-0941 (160 µCi), taken orally as eight 5-mg capsules
Study Arms  ICMJE Experimental: MK-0941
MK-0941
Intervention: Drug: MK-0941
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2009)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00912002
Other Study ID Numbers  ICMJE 0941-016
2008_598
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP