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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644761
• Other study ID #: GS-02-531
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2008
• Last updated: April 7, 2008
• Start date: February 2004
• Est. completion date: May 2005

Study information

• Verified date: April 2008
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Open-label pharmacokinetic drug interaction study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Baylor Research Institute	Dallas	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Columbia Presbyterian Medical Center	New York	New York
United States	NYU Medical Center	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	New York
United States	California Pacific Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation		21 days	No
Secondary	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	No