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

NCT02743247 | Completed Phase 1 DMC

• 1 other identifier: 17-2015-006-4
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Peak Concentration of Tacrolimus and Mycophenolate mofetil

  0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose

• Adverse Drug Reaction

  through study completion, an average of 1 month

Study Arms (1)

Tacrolimus and Mycophenolate mofetil

EXPERIMENTAL

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

Drug: Tacrolimus; Drug: Mycophenolate mofetil

Interventions

Tacrolimus DRUG

Also known as: Prograf

Tacrolimus and Mycophenolate mofetil

Mycophenolate mofetil DRUG

Also known as: Cellcept

Tacrolimus and Mycophenolate mofetil

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Yon Su Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: April 19, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

KR (1)