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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00912002
First received: June 1, 2009
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: MK-0941
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Who Experienced An Adverse Event [ Time Frame: Up to 14 days after study drug administration ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinued the Study Due to An Adverse Event [ Time Frame: Up to 14 days after study drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2008
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912002

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00912002     History of Changes
Other Study ID Numbers: MK-0941-016, 2008_598
Study First Received: June 1, 2009
Results First Received: April 26, 2012
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014