Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Liver Failure
Interventions
DRUG

LCP Tacro

"In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.~LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses.~Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL."

DRUG

Prograf

Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.

Trial Locations (1)

44123

University of Cincinnati, Cincinnati

All Listed Sponsors
collaborator

CTI Clinical Trial and Consulting Services

OTHER

lead

Veloxis Pharmaceuticals

INDUSTRY