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
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 April 22, 2014