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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes
• Intervention: Drug: MK-0941
• Enrollment: 6

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	MK-0941
Arm/Group Description	Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
Period Title: Overall Study
Started	6
Completed	6
Not Completed	0

Baseline Characteristics

Arm/Group Title		MK-0941
Arm/Group Description		Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
Overall Number of Baseline Participants		6
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	6 participants
<29 years		0
29 years to 55 years		6
>55 years		0
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants
	Female	0 0.0%
	Male	6 100.0%

Outcome Measures

1. Primary Outcome

Title	Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).
Description	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%.
Time Frame	Up to 168 hours after study drug administration

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	MK-0941
Arm/Group Description:	Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
Overall Number of Participants Analyzed	6
Mean (Standard Deviation); Unit of Measure: Percent Recovered
In the Urine	60.0 (8.56)
In the Feces	38.7 (8.35)

2. Secondary Outcome

Title	Number of Participants Who Experienced An Adverse Event
Description	[Not Specified]
Time Frame	Up to 14 days after study drug administration

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	MK-0941
Arm/Group Description:	Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: participants
	5

3. Secondary Outcome

Title	Number of Participants Who Discontinued the Study Due to An Adverse Event
Description	[Not Specified]
Time Frame	Up to 14 days after study drug administration

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	MK-0941
Arm/Group Description:	Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: participants
	0

Adverse Events

Time Frame	Up to 14 days after study drug administration
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	MK-0941
Arm/Group Description	Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
All-Cause Mortality
	MK-0941
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	MK-0941
	Affected / at Risk (%)
Total	0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	MK-0941
	Affected / at Risk (%)
Total	5/6 (83.33%)
Eye disorders
Cataract † 1	1/6 (16.67%)
Gastrointestinal disorders
Abdominal pain † 1	1/6 (16.67%)
Abdominal pain lower † 1	1/6 (16.67%)
Dyspepsia † 1	1/6 (16.67%)
Faecal incontinence † 1	1/6 (16.67%)
General disorders
Mucosal dryness † 1	1/6 (16.67%)
Metabolism and nutrition disorders
Decreased appetite † 1	2/6 (33.33%)
Nervous system disorders
Dizziness † 1	1/6 (16.67%)
Headache † 1	1/6 (16.67%)
Tremor † 1	1/6 (16.67%)
Respiratory, thoracic and mediastinal disorders
Epistaxis † 1	1/6 (16.67%)
Skin and subcutaneous tissue disorders
Dermatitis contact † 1	1/6 (16.67%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 14.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

Results Point of Contact

• Name/Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp
• Phone: 1-800-672-6372
• EMail: ClinicalTrialsDisclosure@merck.com

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00912002
• Other Study ID Numbers: 0941-016; 2008_598
• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Results First Submitted: April 26, 2012
• Results First Posted: May 28, 2012
• Last Update Posted: July 3, 2015