Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01422369
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 14

Study Details

Study Description

Brief Summary

This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Pitavastatin (NK-104); Drug: Darunavir/Ritonavir (Prezista)	Phase 4

Detailed Description

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days before admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be 1 treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 12 through 16 and a once daily dose of darunavir/ritonavir 800 mg/100 mg on Days 6 through 16. On Days 1 through 4, 6 through 10, and 12 through 15, study drug will be administered 30 minutes before a standard breakfast. On Days 5, 11, and 16, subjects will fast at least 8 hours before receiving study drug and remain fasted for 4 hours after dosing.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Drug-Drug Interaction Study to Assess the Effects of Steady-State Darunavir/Ritonavir on Steady-State Pitavastatin in Healthy Adult Volunteers
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Subjects pitavastatin 4 mg	Drug: Pitavastatin (NK-104); Pitavastatin (NK-104) 4mg once daily (QD); Drug: Darunavir/Ritonavir (Prezista); Darunavir/Ritonavir (Prezista) 800 mg/100 mg

Outcome Measures

Primary Outcome Measures

1. NK-104 AUC [16 Days]

Secondary Outcome Measures

1. Number of Participants With at Least One Adverse Event. [16 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adult male or female volunteer aged 18 to 45 years, inclusive.

• Subject has a body mass index of 18 to 30 kg/m2, inclusive.

• Subject has normal hematology, serum chemistry, and urinalysis test results

• Subject is able and willing to abstain from alcohol, grapefruit, caffeine or caffeine containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until completion of the study

• Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until study completion.

Exclusion Criteria:

• Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.

• Subject has had a previous allergy or intolerance to treatment with pitavastatin, darunavir, ritonavir, sulfonamides, or any drugs in these classes.

• Subject has a history of drug or alcohol abuse.

• Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Austin	Texas	United States

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

• Study Director: Roger Morgan, MD, FACS, Kowa Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01422369
• Other Study ID Numbers: NK-104-4.06US
• First Posted: Aug 24, 2011
• Last Update Posted: Jul 13, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Kowa Research Institute, Inc.: Healthy Volunteers
• Additional relevant MeSH terms: Ritonavir; Darunavir; Pitavastatin

Study Results

Participant Flow

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

Arm/Group Title	All Subjects
Arm/Group Description	All randomized subjects
Period Title: NK-104 4mg QD
STARTED	28
COMPLETED	28
NOT COMPLETED	0
Period Title: NK-104 4mg QD
STARTED	28
COMPLETED	28
NOT COMPLETED	0
Period Title: NK-104 4mg QD
STARTED	28
COMPLETED	27
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All randomized subjects
Overall Participants	28
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.5 (6.61)
Sex: Female, Male (Count of Participants)
Female	7 25%
Male	21 75%
Region of Enrollment (participants) [Number]
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	NK-104 AUC
Time Frame	16 Days

Outcome Measure Data

Analysis Population Description

All subjects with measurable pharmacokinetic (PK) values.

Arm/Group Title	NK-104
Arm/Group Description	NK-104 4mg once daily (QD)
Measure Participants	27
Mean (Standard Deviation) [ng * h/mL]	192.00 (80.8)

2. Secondary Outcome

Title	Number of Participants With at Least One Adverse Event.
Time Frame	16 Days

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication.

Arm/Group Title	All Subjects
Arm/Group Description	All randomized subjects
Measure Participants	28
Number [Participants]	2 7.1%

Adverse Events

Arm/Group Title	All Subjects
Arm/Group Description	All randomized subjects
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	13/28 (46.4%)
Gastrointestinal disorders
Diarrhea	1/28 (3.6%)
Abdominal pain	1/28 (3.6%)
Nausea	1/28 (3.6%)
Swollen tongue	1/28 (3.6%)
General disorders
Fatigue	2/28 (7.1%)
Feeling cold	1/28 (3.6%)
Musculoskeletal and connective tissue disorders
Myalgia	3/28 (10.7%)
Nervous system disorders
Paresthesia	1/28 (3.6%)
Headache	3/28 (10.7%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	3/28 (10.7%)
Skin and subcutaneous tissue disorders
Dermatitis contact	1/28 (3.6%)
Pruritus	1/28 (3.6%)
Rash maculopapular	1/28 (3.6%)
Urticaria	1/28 (3.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

May not publish.