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

NCT00912002 | Completed Phase 1 Results

• 2 other identifiers: 0941-0162008_598
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).

  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%.

  Up to 168 hours after study drug administration

Secondary Outcomes (2)

• Number of Participants Who Experienced An Adverse Event

  Up to 14 days after study drug administration

• Number of Participants Who Discontinued the Study Due to An Adverse Event

  Up to 14 days after study drug administration

Study Arms (1)

MK-0941

EXPERIMENTAL

MK-0941

Drug: MK-0941

Interventions

MK-0941 DRUG

A single dose of 40 mg of \[14C\]MK-0941 (160 µCi), taken orally as eight 5-mg capsules

MK-0941

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2009
• Last Updated: July 3, 2015
• Results First Posted: May 28, 2012

Record last verified: 2015-06