A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Advagraf®

Drug: Prograf®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01681134

FKC-016

Details and patient eligibility

About

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

Full 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.

Enrollment

19 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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