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Trial record 12 of 1163 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT02743247
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Yon Su Kim, 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Tacrolimus Drug: Mycophenolate mofetil Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
Study Start Date : October 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Experimental: Tacrolimus and Mycophenolate mofetil
Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.
Drug: Tacrolimus
Other Name: Prograf

Drug: Mycophenolate mofetil
Other Name: Cellcept




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


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743247


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea
Investigators
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Principal Investigator: Yon Su Kim, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Yon Su Kim, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02743247     History of Changes
Other Study ID Numbers: 17-2015-006-4
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Yon Su Kim, Seoul National University Hospital:
Healthy volunteer

Additional relevant MeSH terms:
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Mycophenolic Acid
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents