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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-0941

Drug

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

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Investigate the Absorption, Metabolism, Excretion and Mass Balance After Administration of a Single Dose of [14C]MK-0941

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Jun 3, 2009
Registry last updated: Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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