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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01430065
First received: June 30, 2011
Last updated: September 6, 2011
Last verified: September 2011
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples [ Time Frame: Up to Day 13 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01430065     History of Changes
Other Study ID Numbers: 015K-CL-PK02
Study First Received: June 30, 2011
Last Updated: September 6, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014