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Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430065
First Posted: September 7, 2011
Last Update Posted: September 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.

Condition Intervention Phase
Pharmacokinetics of ASP015K Drug Interactions Healthy Subjects Drug: ASP015K Drug: Tacrolimus Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic assessment of AUC through the analysis of blood and urine samples [ Time Frame: Up to Day 13 ]

Secondary Outcome Measures:
  • Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples [ Time Frame: Up to Day 13 ]

Enrollment: 24
Study Start Date: June 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus and ASP015K Drug: ASP015K
oral
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506

Detailed Description:
The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
  • If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
  • Subject is medically healthy, with no clinically significant medical history or abnormalities observed upon physical examination or 12-lead electrocardiogram (ECG)
  • Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

  • Subject has a history of chronic diarrhea
  • Subject has been vaccinated within the last 60 days prior to study drug administration
  • The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease
  • Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
  • Subject has a history of the human immunodeficiency virus (HIV) antibody
  • The subject has an absolute neutrophil count (ANC) < 2500 cells/mm3 Subject has had clinically significant illness within 1 month prior to study drug administration
  • Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430065


Locations
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01430065     History of Changes
Other Study ID Numbers: 015K-CL-PK02
First Submitted: June 30, 2011
First Posted: September 7, 2011
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Astellas Pharma Inc:
transplant
ASP015K
tacrolimus
Prograf
healthy volunteers

Additional relevant MeSH terms:
Tacrolimus
Niacinamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances