Pharmacokinetic of Everolimus and Atorvastatin Co-administration

February 7, 2013 updated by: ANOCHA WANITCHANONT, Chulalongkorn University

Drug Interaction and Pharmacokinetic Assessment of Everolimus When Coadministered With Atorvastatin in Renal Transplantation Recipient

Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Population : Thai postrenal transplantation recipient who received everolimus and have hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn University.

Study Design : Experimental study, Two-sample crossover study Sample size calculation :N = 18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary outcome : renal function (serum creatinine, creatinine clearance)

Method :

  1. Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1 month.
  2. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
  3. After first blood sample, patients will received everolimus only for 1 month (wash out period)
  4. Patients will switch to another arm eg.patient who had received everolimus will switch to everolimus with atorvastatin 20 mg for 1 month
  5. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
  6. Everolimus level will analyse for 12-hour AUC of everolimus.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post renal transplantation recipient who received immunosuppressive drug Everolimus and has hypercholesterolemia
  • Co everolimus level within 3-12 ng/mL
  • Informed consent
  • Patient can follow research methodology

Exclusion Criteria:

  • Patient don't want to participate in the study
  • Post renal transplantation recipient who have normal lipid profile

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: everolimus
Everolimus administration with adjusted dose to target C trough (C0) level between 3-12 ng/mL
Drug: Atorvastatin 20 mg
Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg
Other Names:
  • Lipitor 20 mg
Experimental: everolimus with atorvastatin 20 mg

Co-administration of everolimus and atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.

Atorvastatin 20 mg/day (fixed dose)
Drug: Everolimus
Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.
Other Names:
  • Everolimus alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-hour area under the time concentration curve of everolimus
Time Frame: 3 months
compare when taking only everolimus to coadministered with atorvastatin
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function
Time Frame: 3 months
Renal function : serum creatinine, 24 hour creatinine clearance 24 hour urine protein, Urinalysis Sample take at month 0,1,2,3
3 months
Liver function test
Time Frame: 3 month
Total protein, Albumin, total bilirubin, direct bilirubin, AST, ALT, Alkaline phosphatase at month 0,1,2,3
3 month
Lipid profile
Time Frame: 3 month
Total cholesterol, Triglyceride, HDL, LDL at month 0,1,2,3
3 month
Rhabdomyolysis
Time Frame: 3 month
Adverse drug reaction from atorvastatin by measured CPK at month 0,1,2,3
3 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of 12-hour AUC and point of everolimus level
Time Frame: 3 months
To correlate between 12-hour AUC and point of everolimus level
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Ratchadapiseksompotch Research Fund

Investigators

  • Principal Investigator: Anocha Wanitchanont, MD., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7478

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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