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Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

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ClinicalTrials.gov Identifier: NCT01057433
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : August 13, 2012
Last Update Posted : August 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 Volunteers
Interventions Drug: Pitavastatin (NK-104)
Drug: Lopinavir/ritonavir
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 24
Completed 23
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title All Subjects
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
33.8  (8.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
12
  50.0%
Male
12
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Area Under the Curve From Time 0 to Tau (AUC 0-τ)
Hide Description Area under the curve from start to elimination.
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
113.92  (53.80)
2.Secondary Outcome
Title Adverse Events
Hide Description [Not Specified]
Time Frame 24 Days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Subjects
Affected / at Risk (%)
Total   18/24 (75.00%) 
Gastrointestinal disorders   
Diarrhea  13/24 (54.17%) 
Abdominal pain  10/24 (41.67%) 
Nausea  8/24 (33.33%) 
Anal hemorrhage  4/24 (16.67%) 
Flatulence  4/24 (16.67%) 
Dyspepsia  3/24 (12.50%) 
Constipation  2/24 (8.33%) 
Nervous system disorders   
Headache  6/24 (25.00%) 
Dysgeusia  3/24 (12.50%) 
Dizziness  2/24 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  3/24 (12.50%) 
Rhinorrhea  2/24 (8.33%) 
Skin and subcutaneous tissue disorders   
Dermatitis contact  3/24 (12.50%) 
Rash macular  2/24 (8.33%) 
1
Term from vocabulary, MedDRA
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
Layout table for Results Point of Contact information
Name/Title: Roger Morgan, MD, FACS
Organization: Kowa Research Institute, Inc.
Phone: 919-433-1600
EMail: RMorgan@KowaUS.com
Layout table for additonal information
Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01057433     History of Changes
Other Study ID Numbers: NK-104-4.02US
First Submitted: January 25, 2010
First Posted: January 27, 2010
Results First Submitted: March 23, 2012
Results First Posted: August 13, 2012
Last Update Posted: August 13, 2012