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NCT00176033 Clinical Trial

Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra

Healthy Clinical Trial

Official title:
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra (Lopinavir/Ritonavir) and on the Concentration Relations Between Plasma, Blood Cells, Saliva and Urine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00176033
Other study ID # K026
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated February 12, 2009
Start date January 2005

Study information
Verified date February 2009
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the two protease inhibitors. The latter will be studied by comparing intracellular concentrations of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in healthy individuals. These effects will be studied after single dose (day 1), during steady state (day 3), and during chronic treatment (day 14).

Description:

Objective:

Measurement of AUC, Cmax, tmax, t1/2 and clearance (Cl) of the protease inhibitor Kaletra™ (lopinavir and ritonavir) each in the plasma of healthy individuals

- establish free and total plasma - blood cell concentration-relationship

- establish free and total plasma - saliva concentration-relationship

- establish blood cell concentration - drug transporter expression-relationship

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Good state of health

Exclusion Criteria:

- Drug treatment with known inhibitors or inducers of cytochrome P450 isozymes or ABC-transporters within the preceding 2 months

- Any acute or chronic illness

- Smoking

- Pregnancy

- Alcohol or drug abuse

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Clinical Research Center, Department of Internal Medicine VI Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

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