The clinical trial is expected to enroll up to 50 patients in up to 12 centers throughout the US.
The Phase II clinical trial is a three-sequence, open-label, multi-center conversion study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24 and AUC) and safety of LCP-Tacro tablets once-a-day versus Prograf (tacrolimus) capsules twice-a-day.
At the conclusion of the clinical trial each eligible patient will be given the opportunity to rollover to, and participate in, a 52-week open-label extension study in which they will receive LCP-Tacro. The company expects to report clinical trial results in the first half of 2008.
Kenneth Washburn, professor of surgery, head of liver transplantation at the University of Texas Health Science Center at San Antonio, said: “We are excited to participate in the first clinical trial of LCP-Tacro in liver transplant patients. It’s important that transplant patients and physicians have reliable options for the management of immunosuppression and we believe LCP-Tacro may make a real difference in patients’ lives.”