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Drug-Drug Interaction Study With Pravastatin and Cyclosporine

NCT01497483 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-01-16

No results posted yet for this study

Summary

This study will address the following question: Does cyclosporine affect the pharmacokinetics of pravastatin in healthy volunteers? Studies have shown that cyclosporine inhibits the organic anion transporter required for pravastatin transport into the liver, thus increasing pravastatin levels in the blood. The investigators hypothesize that this inhibition will vary among people based on genetic differences. This knowledge is important to help develop safer and more effective drug therapy with reduced side effects.

Conditions

  • Healthy

Interventions

DRUG

Pravastatin alone

Pravastatin 40 mg with placebo.

DRUG

Pravastatin and Cyclosporine

Pravastatin 40 mg co-administered with 200 mg of cyclosporine.

Sponsors & Collaborators

Principal Investigators

  • Deanna Kroetz, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-05-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497483 on ClinicalTrials.gov