Pharmacokinetic of Everolimus and Atorvastatin Co-administration
Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Difference of 12-hour AUC
Intervention: Atorvastatin 20 mg (Drug); Everolimus (Drug)
Phase: N/A
Status: Completed
Sponsored by: Chulalongkorn University Official(s) and/or principal investigator(s): Anocha Wanitchanont, MD., Principal Investigator, Affiliation: Chulalongkorn University
Summary
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.
Clinical Details
Official title: Drug Interaction and Pharmacokinetic Assessment of Everolimus When Coadministered With Atorvastatin in Renal Transplantation Recipient
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: 12-hour area under the time concentration curve of everolimus
Secondary outcome: Renal functionLiver function test Lipid profile Rhabdomyolysis
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand
Additional Information
Related publications: Kovarik JM, Hartmann S, Hubert M, Berthier S, Schneider W, Rosenkranz B, Rordorf C. Pharmacokinetic and pharmacodynamic assessments of HMG-CoA reductase inhibitors when coadministered with everolimus. J Clin Pharmacol. 2002 Feb;42(2):222-8.
Starting date: September 2012
Last updated: February 7, 2013
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