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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-0941
Hide 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
Arm/Group Title MK-0941
Hide 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
Hide 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%
1.Primary Outcome
Title Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title MK-0941
Hide 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
Hide Description [Not Specified]
Time Frame Up to 14 days after study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title MK-0941
Hide 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
Hide Description [Not Specified]
Time Frame Up to 14 days after study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title MK-0941
Hide 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
Time Frame Up to 14 days after study drug administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-0941
Hide 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   --/-- 
Hide Serious Adverse Events
MK-0941
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
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