Open-label pharmacokinetic drug interaction study.
Multi-center, phase 2, open-label, sequential-cohort, drug interaction study. Cohort 1 subjects (tacrolimus and adefovir dipivoxil) were enrolled first. Based on the findings in Cohort 1, a decision was made on whether to enroll subjects in Cohort 2 (cyclosporine and adefovir dipivoxil)(i.e., if no interaction was observed in Cohort 1, Cohort 2 subjects would not be enrolled). Since no pharmacokinetic interaction was observed in Cohort 1, Cohort 2 was not enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation
Time frame: 21 days
To evaluate PK of ADV 10 mg once daily when co-administered with tacrolimus or cyclosporine in patients post-liver transplantation. To evaluate the safety of ADV 10 mg once daily, when co-administered with tacrolimus or cyclosporine for 14 days.
Time frame: 21 days
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University of California, San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NYU Medical Center
New York, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Mayo Clinic
Rochester, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
...and 1 more locations