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Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

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ClinicalTrials.gov Identifier: NCT01422369
Recruitment Status : Completed
First Posted : August 24, 2011
Results First Posted : March 15, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Pitavastatin (NK-104)
Drug: Darunavir/Ritonavir (Prezista)
Enrollment 28
Recruitment Details 1st Subject Enrolled 20 April 2011 Last Subject Completed 10 June 2011
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description All randomized subjects
Period Title: NK-104 4mg QD
Started 28
Completed 28
Not Completed 0
Period Title: Prezista 800mg/100mg QD
Started 28
Completed 28
Not Completed 0
Period Title: NK-104 4mg QD & Prezista 800mg/100mg QD
Started 28
Completed 27
Not Completed 1
Arm/Group Title All Subjects
Hide Arm/Group Description All randomized subjects
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
30.5  (6.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
7
  25.0%
Male
21
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title NK-104 AUC
Hide Description [Not Specified]
Time Frame 16 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects with measurable pharmacokinetic (PK) values.
Arm/Group Title NK-104
Hide Arm/Group Description:
NK-104 4mg once daily (QD)
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: ng * h/mL
192.00  (80.8)
2.Secondary Outcome
Title Number of Participants With at Least One Adverse Event.
Hide Description [Not Specified]
Time Frame 16 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication.
Arm/Group Title All Subjects
Hide Arm/Group Description:
All randomized subjects
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: Participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description All randomized subjects
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
All Subjects
Affected / at Risk (%)
Total   13/28 (46.43%) 
Gastrointestinal disorders   
Diarrhea * 1  1/28 (3.57%) 
Abdominal pain * 1  1/28 (3.57%) 
Nausea * 1  1/28 (3.57%) 
Swollen tongue * 1  1/28 (3.57%) 
General disorders   
Fatigue * 1  2/28 (7.14%) 
Feeling cold * 1  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  3/28 (10.71%) 
Nervous system disorders   
Paresthesia * 1  1/28 (3.57%) 
Headache * 1  3/28 (10.71%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain * 1  3/28 (10.71%) 
Skin and subcutaneous tissue disorders   
Dermatitis contact * 1  1/28 (3.57%) 
Pruritus * 1  1/28 (3.57%) 
Rash maculopapular * 1  1/28 (3.57%) 
Urticaria * 1  1/28 (3.57%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MEDRA v. 14.0
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.
May not publish.
Results Point of Contact
Name/Title: Roger Morgan, MD FACS
Organization: Kowa Research Institute, Inc
Phone: 919-433-1600
Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01422369     History of Changes
Other Study ID Numbers: NK-104-4.06US
First Submitted: August 22, 2011
First Posted: August 24, 2011
Results First Submitted: January 3, 2012
Results First Posted: March 15, 2012
Last Update Posted: July 13, 2012