Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

Healthy Volunteers Clinical Trial

Official title:

Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057433
• Other study ID #: NK-104-4.02US
• Status: Completed
• Phase: Phase 4
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2021
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
• Lopinavir/ritonavir
lopinavir/ritonavir 800 mg/200 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time 0 to Tau (AUC 0-t)	Area under the curve from start to elimination.	0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24