PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients

A Multi-Center Phase 2, Open-Label Study to Evaluate the Pharmacokinetics of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil 10 mg to Patients Post-Liver Transplantation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644761

Enrollment

Registered

2008-03-27

Start date

2004-02-29

Completion date

2005-05-31

Last updated

2008-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B, Post-Liver Transplantation, Adefovir Dipivoxil, Tacrolimus, Cyclosporine

Brief summary

Open-label pharmacokinetic drug interaction study.

Detailed description

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.

Interventions

DRUGAdefovir Dipivoxil

Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 18-65 years of age * Greater than or equal to 6 months post-liver transplantation * Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months. * Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault method).

Design outcomes

Primary

Measure	Time frame
To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation	21 days

Secondary

Measure	Time frame
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.	21 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026