A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00830791
First received: January 26, 2009
Last updated: January 24, 2014
Last verified: January 2014
Results First Received: May 1, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: MK-0941 20 mg
Drug: MK-0941 5 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MK-0941 20 mg Mild Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
Control + MK-0941 20 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 20 mg Moderate Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
Control + 20 mg MK-0941 Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 5 mg Severe Renal Insufficiency MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
Control + MK-0941 5 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.

Participant Flow:   Overall Study
    MK-0941 20 mg Mild Renal Insufficiency     Control + MK-0941 20 mg     MK-0941 20 mg Moderate Renal Insufficiency     Control + 20 mg MK-0941     MK-0941 5 mg Severe Renal Insufficiency     Control + MK-0941 5 mg  
STARTED     8     8     8     8     0     0  
COMPLETED     8     8     8     8     0     0  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MK-0941 20 mg Mild Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
Control + MK-0941 20 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 20 mg Moderate Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
Control + 20 mg MK-0941 Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 5 mg Severe Renal Insufficiency MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
Control + MK-0941 5 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
Total Total of all reporting groups

Baseline Measures
    MK-0941 20 mg Mild Renal Insufficiency     Control + MK-0941 20 mg     MK-0941 20 mg Moderate Renal Insufficiency     Control + 20 mg MK-0941     MK-0941 5 mg Severe Renal Insufficiency     Control + MK-0941 5 mg     Total  
Number of Participants  
[units: participants]
  8     8     8     8     0     0     32  
Age  
[units: participants]
             
<=18 years     0     0     0     0             0  
Between 18 and 65 years     6     6     7     7             26  
>=65 years     2     2     1     1             6  
Gender  
[units: participants]
             
Female     6     6     5     5             22  
Male     2     2     3     3             10  



  Outcome Measures
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1.  Primary:   Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls   [ Time Frame: 72 Hours Post-Dose ]

2.  Primary:   Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

3.  Primary:   Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

4.  Secondary:   Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

5.  Secondary:   Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

6.  Secondary:   Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

7.  Secondary:   Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

8.  Secondary:   Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

9.  Secondary:   Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

10.  Secondary:   Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

11.  Secondary:   T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

12.  Secondary:   T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls   [ Time Frame: 72-Hours Post-Dose ]

13.  Secondary:   Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls   [ Time Frame: 36-Hours Post-Dose ]

14.  Secondary:   Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls   [ Time Frame: 36-Hours Post-Dose ]

15.  Secondary:   Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls   [ Time Frame: 36-Hours Post-Dose ]

16.  Secondary:   CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls   [ Time Frame: 36-Hours Post-Dose ]

17.  Secondary:   CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls   [ Time Frame: 36-Hours Post-Dose ]

18.  Secondary:   CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls   [ Time Frame: 36-Hours Post-Dose ]

19.  Secondary:   Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls   [ Time Frame: Up to 12 Hours Post-Dose ]

20.  Secondary:   Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls   [ Time Frame: Up to 12 Hours Post-Dose ]

21.  Secondary:   Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls   [ Time Frame: Up to 12 Hours Post-Dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: (800) 672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00830791     History of Changes
Other Study ID Numbers: 0941-015, 2009_522
Study First Received: January 26, 2009
Results First Received: May 1, 2012
Last Updated: January 24, 2014
Health Authority: Russia: Pharmacological Committee, Ministry of Health