Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01422369
First received: August 22, 2011
Last updated: July 5, 2012
Last verified: July 2012
Results First Received: January 3, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Pitavastatin (NK-104)
Drug: Darunavir/Ritonavir (Prezista)

  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
1st Subject Enrolled 20 April 2011 Last Subject Completed 10 June 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subjects All randomized subjects

Participant Flow for 3 periods

Period 1:   NK-104 4mg QD
    All Subjects  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  

Period 2:   Prezista 800mg/100mg QD
    All Subjects  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  

Period 3:   NK-104 4mg QD & Prezista 800mg/100mg QD
    All Subjects  
STARTED     28  
COMPLETED     27  
NOT COMPLETED     1  



  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.
No text entered.

Reporting Groups
  Description
All Subjects All randomized subjects

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  28  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.5  ± 6.61  
Gender  
[units: participants]
 
Female     7  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures
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1.  Primary:   NK-104 AUC   [ Time Frame: 16 Days ]

2.  Secondary:   Number of Participants With at Least One Adverse Event.   [ Time Frame: 16 Days ]


  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 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: Roger Morgan, MD FACS
Organization: Kowa Research Institute, Inc
phone: 919-433-1600
e-mail: RMorgan@kowaus.com


No publications provided by Kowa Research Institute, Inc.

Publications automatically indexed to this study:

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01422369     History of Changes
Other Study ID Numbers: NK-104-4.06US
Study First Received: August 22, 2011
Results First Received: January 3, 2012
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration