Pharmacokinetic of Everolimus and Atorvastatin Co-administration

NCT01780948 | Completed

• 1 other identifier: A7478
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Difference of 12-hour AUC

Keywords

Drug Interaction; Pharmacokinetics; Everolimus; Atorvastatin

Outcome Measures

Primary Outcomes (1)

• 12-hour area under the time concentration curve of everolimus

  compare when taking only everolimus to coadministered with atorvastatin

  3 months

Secondary Outcomes (4)

• Renal function

  3 months

• Liver function test

  3 month

• Lipid profile

  3 month

• Rhabdomyolysis

  3 month

Other Outcomes (1)

• Correlation of 12-hour AUC and point of everolimus level

  3 months

Study Arms (2)

everolimus

PLACEBO COMPARATOR

Everolimus administration with adjusted dose to target C trough (C0) level between 3-12 ng/mL

Drug: Atorvastatin 20 mg

everolimus with atorvastatin 20 mg

EXPERIMENTAL

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

Interventions

Atorvastatin 20 mg DRUG

Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg

Also known as: Lipitor 20 mg

everolimus

Everolimus DRUG

Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.

Also known as: Everolimus alone

everolimus with atorvastatin 20 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead
• Ratchadapiseksompotch Research Fund: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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. doi: 10.1177/00912700222011148.

  PMID: 11831546 BACKGROUND

MeSH Terms

Interventions

Atorvastatin; Everolimus

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Anocha Wanitchanont, MD.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medicine, Faculty of Medicine, Chulalongkorn University

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

TH (1)