Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults

Overview

Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil, therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction between two drugs is still not well understood. Therefore, an open-label, three period, single dose trial is planned to investigate the drug interaction between tacrolimus and mycophenolate mofetil.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2016

Detailed Description

Study consists of three periods with fixed sequence: 1) single dose of mycophenolate mofetil 1,000mg; 2) single dose of tacrolimus 5mg; 3) single dose of mycophenolate mofetil 1,000mg and tacrolimus 5mg. All subjects have one week of washing period between single dose administration. Blood samples are drawn up to 72 hours after drug administration. Single nucleotide polymorphisms known to result in pharmacokinetic variability of study drug are also investigated. Drug interaction is going to be assessed through the ratio of area under the concentration curve of one drug in the presence or absence of another drug.

Interventions

  • Drug: Tacrolimus
  • Drug: Mycophenolate mofetil

Arms, Groups and Cohorts

  • Experimental: Tacrolimus and Mycophenolate mofetil
    • Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.

Clinical Trial Outcome Measures

Primary Measures

  • Area under the concentration versus time curve (AUC) of Tacrolimus and Mycophenolate mofetil
    • Time Frame: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose

Secondary Measures

  • Peak Concentration of Tacrolimus and Mycophenolate mofetil
    • Time Frame: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
  • Adverse Drug Reaction
    • Time Frame: through study completion, an average of 1 month

Participating in This Clinical Trial

Inclusion Criteria

  • Male adult with age of 19-45 – Weight difference between ideal and actual body weight is less than 20% – Previous healthy with no known disease – Considered normal on physical exam, clinical laboratory tests(complete blood count, electrolyte, renal and hepatic function) and electrocardiogram – Never been heavy-drinker within one month prior to trial initiation and able to abstain from alcohol during trial Exclusion Criteria:

  • Ever smoked within one year prior to trial initiation – Took other drugs (including herbal medicine) within one month prior to trial initiation – Alcohol or drug abuser – Participated another clinical trial within three months – Considered inadequate under investigator's discretion

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Ministry of Food and Drug Safety, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yon Su Kim, Principal Investigator – Seoul National University Hospital
  • Overall Official(s)
    • Yon Su Kim, M.D., Ph.D., Principal Investigator, Seoul National University Hospital

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