Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

• Sponsor: Kowa Research Institute, Inc.
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	All Subjects
Arm/Group Description	[Not Specified]
Period Title: Overall Study
Started	24
Completed	23
Not Completed	1
Reason Not Completed
Adverse Event	1

Baseline Characteristics

Arm/Group Title		All Subjects
Arm/Group Description		[Not Specified]
Overall Number of Baseline Participants		24
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

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve From Time 0 to Tau (AUC 0-τ)
Description	Area under the curve from start to elimination.
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Subjects
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
Description	[Not Specified]
Time Frame	24 Days

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	All Subjects
Arm/Group Description	[Not Specified]
All-Cause Mortality
	All Subjects
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)
Total	0/24 (0.00%)
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 1	13/24 (54.17%)
Abdominal pain 1	10/24 (41.67%)
Nausea 1	8/24 (33.33%)
Anal hemorrhage 1	4/24 (16.67%)
Flatulence 1	4/24 (16.67%)
Dyspepsia 1	3/24 (12.50%)
Constipation 1	2/24 (8.33%)
Nervous system disorders
Headache 1	6/24 (25.00%)
Dysgeusia 1	3/24 (12.50%)
Dizziness 1	2/24 (8.33%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 1	3/24 (12.50%)
Rhinorrhea 1	2/24 (8.33%)
Skin and subcutaneous tissue disorders
Dermatitis contact 1	3/24 (12.50%)
Rash macular 1	2/24 (8.33%)
1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

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.

May not publish.

Results Point of Contact

Name/Title: Roger Morgan, MD, FACS

Organization: Kowa Research Institute, Inc.

Phone: 919-433-1600

EMail: RMorgan@KowaUS.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Morgan RE, Campbell SE, Suehira K, Sponseller CA, Yu CY, Medlock MM. Effects of steady-state lopinavir/ritonavir on the pharmacokinetics of pitavastatin in healthy adult volunteers. J Acquir Immune Defic Syndr. 2012 Jun 1;60(2):158-64. doi: 10.1097/QAI.0b013e318251addb.

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