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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Canada, Inc.
• Treatments: Tacrolimus

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