A Comparison of Effects of Short-Term Steady State Low Dose Exposure of Extended Release (Advagraf®) and Immediate Release (Prograf®) Formulations of Tacrolimus on Renal Perfusion and Function in Healthy Male Volunteers

Astellas Pharma Canada, Inc.1 site in 1 country19 target enrollmentJuly 2012

ConditionsHealthy

InterventionsAdvagraf®Prograf®

DrugsAdvagraf®Prograf®

Overview

Phase: Phase 1
Intervention: Advagraf®
Conditions: Healthy
Sponsor: Astellas Pharma Canada, Inc.
Enrollment: 19
Locations: 1
Primary Endpoint: Effective Renal Plasma Flow (ERPF)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.

Detailed Description

This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Astellas Pharma Canada, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Caucasian
•No previous/current history of infection, cerebrovascular, neurological, cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant systemic disease, glucose intolerance, gout or hematological disorder
•Normal 12-lead Electrocardiogram (ECG)
•Systolic blood pressure \<140 mm Hg and diastolic blood pressure \<90 mm Hg
•Non-smoker within 3 months prior to screening
•Willing to abstain from alcohol during the study

Exclusion Criteria

•Positive screen for illicit drug or alcohol consumption
•Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of cancer (excluding completely excised squamous or basal cell carcinoma)
•Positive tuberculin skin test or known history of tuberculosis infection
•Known history of serious head injuries, seizures or eating disorders
•Body Mass Index \<18.0 or \>30.0
•History of renal dysfunction, clinically significant creatinine or clinically significant abnormal liver function tests, hemoglobin \<130 g/L
•Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first dose of study drug.
•Drug or alcohol abuse within 1 year prior to study entry
•Steroid injections within 12 weeks prior to first dose of study drug
•Live vaccine within 7 days prior to first dose of study drug