Healthy
Conditions
Keywords
tacrolimus, Advagraf®, Prograf®, Glomerular Filtration Rate, Effective Renal Plasma Flow, Pharmacokinetics, Pharmacodynamics
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.
Sponsors
Astellas Pharma Canada, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Renal Plasma Flow (ERPF) | up to Day 20 | Estimated by aminohippurate sodium (PAH) clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glomerular Filtration Rate (GFR) | Pre-dose (Day -4), Day 10, Day 20 | Estimated by sinistrin clearance |
Countries
Canada
Outcome results
None listed