Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: MK-0941 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. Number of Participants Who Experienced An Adverse Event [ Time Frame: Up to 14 days after study drug administration ]
  2. Number of Participants Who Discontinued the Study Due to An Adverse Event [ Time Frame: Up to 14 days after study drug administration ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912002


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00912002    
Other Study ID Numbers: 0941-016
2008_598
First Posted: June 3, 2009    Key Record Dates
Results First Posted: May 28, 2012
Last Update Posted: July 3, 2015
Last Verified: June 2015