Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01059851
First received: January 28, 2010
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: August 19, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Insomnia
Intervention: Drug: Suvorexant

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
16 participants were enrolled in Part I of the study. Because the primary hypothesis was met in Part I, no participants were enrolled in Part II of the study.

Reporting Groups
  Description
Participants With Severe Renal Impairment (Part I)

Participants with severe renal impairment received a

single dose of 20 mg open-label suvorexant.

Healthy Participants (Severe Impairment Controls) (Part I) Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
Participants With Moderate Renal Impairment (Part II) Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
Healthy Participants (Moderate Impairment Controls) (Part II) Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
Participants With Mild Renal Impairment (Part II) Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
Healthy Participants (Mild Impairment Controls) (Part II) Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.

Participant Flow:   Overall Study
    Participants With Severe Renal Impairment (Part I)     Healthy Participants (Severe Impairment Controls) (Part I)     Participants With Moderate Renal Impairment (Part II)     Healthy Participants (Moderate Impairment Controls) (Part II)     Participants With Mild Renal Impairment (Part II)     Healthy Participants (Mild Impairment Controls) (Part II)  
STARTED     8     8     0     0     0     0  
COMPLETED     8     8     0     0     0     0  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Baseline characteristics were only presented for participants in Part I of the study (N=16). No participants were enrolled in Part II of the study.

Reporting Groups
  Description
Participants With Severe Renal Impairment (Part I)

Participants with severe renal impairment received a

single dose of 20 mg open-label suvorexant.

Healthy Participants (Part I) Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
Total Total of all reporting groups

Baseline Measures
    Participants With Severe Renal Impairment (Part I)     Healthy Participants (Part I)     Total  
Number of Participants  
[units: participants]
  8     8     16  
Age  
[units: years]
Mean ± Standard Deviation
  50.6  ± 12.5     48.1  ± 11.6     49.4  ± 11.7  
Gender  
[units: participants]
     
Female     5     5     10  
Male     3     3     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)   [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose ]

2.  Primary:   AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)   [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose ]

3.  Primary:   Number of Participants With an Adverse Event (AE)   [ Time Frame: From administration of study drug through 14 days after administration of study drug ]

4.  Primary:   Number of Participants Who Discontinued Study Due to an AE   [ Time Frame: From administration of study drug through 14 days after administration of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide 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 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01059851     History of Changes
Other Study ID Numbers: 4305-023, 2010_505
Study First Received: January 28, 2010
Results First Received: August 19, 2014
Last Updated: August 19, 2014
Health Authority: Russia: Pharmacological Committee, Ministry of Health