Comparison of Extended Release Tacrolimus (Advagraf) and Cyclosporine A Microemulsion on Renal Function in Healthy Volunteers

NCT00818194 | Completed Phase 1

• 2 other identifiers: FKC-012Health Canada Control # 119562
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of steady state tacrolimus vs. cyclosporine on renal pharmacodynamics in healthy volunteers.

Conditions

Healthy

Keywords

Tacrolimus; cyclosporine A; renal plasma flow; glomerular filtration rate; human; pharmacodynamics; pharmacokinetics; Pharmacodynamics of tacrolimus

Outcome Measures

Primary Outcomes (1)

• Comparison of Effective Renal Plasma Flow response

  Baseline and Day 10 of each dosing interval

Secondary Outcomes (2)

• Comparison of Glomerular Filtration Rate response

  Baseline and Day 10 of each dosing interval

• Comparison of blood pressure response

  Baseline and Day 10 of each dosing interval

Study Arms (2)

A. tacrolimus first

EXPERIMENTAL

Subjects receive extended release tacrolimus in first dosing interval then cross over to cyclosporine A for second dosing interval

Drug: extended release tacrolimus; Drug: cyclosporine A microemulsion

B. cyclosporine first

EXPERIMENTAL

Subjects receive cyclosporine A in first dosing interval then cross over to extended release tacrolimus for second dosing interval

Drug: extended release tacrolimus; Drug: cyclosporine A microemulsion

Interventions

extended release tacrolimus DRUG

oral

Also known as: Advagraf®, FK506E, MR4

A. tacrolimus first; B. cyclosporine first

cyclosporine A microemulsion DRUG

oral

Also known as: Neoral®

A. tacrolimus first; B. cyclosporine first

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• caucasian
• healthy with no history or current clinical findings of infection or disease of the following nature: cerebrovascular, neurologic, cardiovascular, endocrine, pulmonary, immunologic, metabolic, hematologic, diabetes mellitus, glucose intolerance, gout
• non-smoker and willing to abstain from alcohol consumption during the study
• agrees to use appropriate contraception during the study period until 3 months after the final study exam.

You may not qualify if:

• history of significant alcohol abuse or drug abuse within 1 year prior to the screening visit
• regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week)
• use of soft drugs (marijuana) within 3 months prior to the screening visit or hard drugs (cocaine, PCP, crack) within 1 year prior to the screening visit Hepatitis B or C, HIV, history of cancer (excluding excised squamous or basal cell carcinoma)
• positive tuberculin skin test or prior TB infection
• known history of serious head injuries, seizures or any eating disorder
• received an investigational drug within 30 days prior to the first study drug administration
• known hypersensitivity/allergy to tacrolimus, cyclosporine, iothalamate iodine, para-aminohippuric acid, antibiotics or antifungals
• Body mass index (BMI) \<19 or \>27
• clinically significant history of psychiatric disease or a significant disability that prevents understanding or adherence to protocol
• renal dysfunction, serum creatinine or urine microalbumin above the normal age and gender-adjusted reference range of the local lab
• clinically significant abnormal liver function test indicative of impaired hepatic function
• received medications/herbal preparations that may affect the metabolism of tacrolimus or cyclosporine A within 1 month of the first study drug administration
• received any other prescription medication within 14 days prior to the first study drug administration or any over-the-counter product within 7 days prior to the first study drug administration, except for topical products without systemic absorption
• current GI condition known to affect GI motility and/or absorption
• donation of plasma (500 mL) within 7 days prior to the first study drug administration or donation/ loss of whole blood as follows: 50 mL to 499 mL within 30 days or more than 499 mL within 56 days prior to the first study drug administration

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Canada, Inc.: collaborator

Study Sites (1)

Unknown Facility

Montreal, Quebec, H3X 2H9, Canada

Location

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Use Central Contact

  Astellas Pharma Canada, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

CA (1)