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

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

Period 2: Prezista 800mg/100mg QD

Period 3: NK-104 4mg QD & Prezista 800mg/100mg QD

Baseline Characteristics

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

1. Primary:

NK-104 AUC [ Time Frame: 16 Days ]

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information