Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of
medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf®
capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a
transplanted kidney and liver. LCP-Tacro is a tablet containing the same active ingredient
(tacrolimus) that is in Prograf capsules, but the tablet has been designed to release
tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is
an investigational drug.
This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a
liver transplant in patients randomly assigned (by chance, like flipping a coin) to take
either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In
addition, patients will remain on study drug for 360 days in order to evaluate the relative
safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.
Phase:
Phase 2
Details
Lead Sponsor:
Veloxis Pharmaceuticals
Collaborators:
Aptuit Inc. CTI Clinical Trial and Consulting Services