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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: Pitavastatin (NK-104) Drug: Lopinavir/ritonavir | Phase 4 |
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 prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 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 Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Pitavastatin
Healthy adult subjects
|
Drug: Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
Other Name: Livalo Drug: Lopinavir/ritonavir lopinavir/ritonavir 800 mg/200 mg
Other Name: Kaletra |
- Area Under the Curve From Time 0 to Tau (AUC 0-τ) [ Time Frame: 12 hours ]Area under the curve from start to elimination.
- Adverse Events [ Time Frame: 24 Days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
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 for 4 days before Day 1 until after completion of this study.
- Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug.
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 or lopinavir/ritonavir.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057433
United States, Texas | |
Austin, Texas, United States |
Study Director: | Roger Morgan, MD, FACS | Kowa Research Institute, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kowa Research Institute, Inc. |
ClinicalTrials.gov Identifier: | NCT01057433 History of Changes |
Other Study ID Numbers: |
NK-104-4.02US |
First Posted: | January 27, 2010 Key Record Dates |
Results First Posted: | August 13, 2012 |
Last Update Posted: | August 13, 2012 |
Last Verified: | July 2012 |
Keywords provided by Kowa Research Institute, Inc.:
Healthy Volunteers |
Additional relevant MeSH terms:
Ritonavir Lopinavir Pitavastatin HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |
Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |