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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tacrolimus; Drug: Mycophenolate mofetil

• Registration Number: NCT02743247
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-18
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-19
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus and Mycophenolate mofetil	Tacrolimus	Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.
Tacrolimus and Mycophenolate mofetil	Mycophenolate mofetil	Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of