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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis B

Treatments: Drug: Adefovir Dipivoxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644761

GS-02-531

Details and patient eligibility

About

Open-label pharmacokinetic drug interaction study.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Treatment Arm 1

Other group

Description:

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

Treatment:

Drug: Adefovir Dipivoxil