Clinical trial NCT02743247: Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
Official title: Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2016-04-19
Enrollment: 18
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Area under the concentration versus time curve (AUC) of Tacrolimus and Mycophenolate mofetil
timeFrame: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
Secondary outcomes:
measure: Peak Concentration of Tacrolimus and Mycophenolate mofetil
timeFrame: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
measure: Adverse Drug Reaction
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yon Su Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: