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

NCT ID: NCT02743247

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-04-30

Brief Summary

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.

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Tacrolimus and Mycophenolate mofetil

Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.

Group Type: EXPERIMENTAL

Tacrolimus

Intervention Type: DRUG

Mycophenolate mofetil

Intervention Type: DRUG

Interventions

Tacrolimus

Intervention Type: DRUG

Mycophenolate mofetil

Intervention Type: DRUG

Other Intervention Names

Prograf; Cellcept

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Food and Drug Safety, Korea

OTHER_GOV

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yon Su Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yon Su Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

17-2015-006-4

Identifier Type: -

Identifier Source: org_study_id