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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veloxis Pharmaceuticals
• Collaborators: Aptuit Inc.; CTI Clinical Trial and Consulting Services
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Adult men and women at least 18 years of age who are recipients of a liver transplant from a deceased donor with a Model for End-Stage Liver Disease (MELD) score at the time of transplantation of ≤ 30 who are able to give informed consent for participation

Exclusion Criteria:

• Recipient of any transplanted organ other than a liver

• Recipients of a liver from a non-heart beating donor

• Recipients of a liver from an ABO incompatible donor

• Recipients of a bone marrow or stem cell transplant

• Patients with a white blood cell count ≤ 2.8 x 109/L unless the absolute neutrophil count (ANC) is > 1.0 x 109/L

• Patients who fail a drugs of abuse screen in the pre-transplant evaluation

• Patients unable to swallow study medication

• Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol

• Pregnant or nursing women (women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication)

• Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception throughout the duration of the study

• Patients who were treated with any other investigational agent in the 30 days prior to enrollment

• Patients seropositive for human immunodeficiency virus (HIV)

• Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully, or hepatocellular carcinoma (HCC) that meet the Milan Criteria for liver transplantation

• Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives

• Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus

• Patients with a known hypersensitivity to tacrolimus

• Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator

Randomization to one of two treatment groups will be done post transplantation provided that the patient fulfills the following additional criteria:

• Patient is able to receive their first dose of randomized study drug orally within 72 hours after the transplant surgery (graft reperfusion)

• Patient was NOT given intravenous tacrolimus prior to their first oral dose of study medication

• Recipient of a liver with a cold ischemia time of ≤ 10 hours