A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01190670
First received: August 11, 2010
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.


Condition Intervention Phase
Healthy
Pharmacokinetics of ASP015K and Tacrolimus
Drug: Tacrolimus
Drug: ASP015K
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1, Open Label, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic variables assessment through analysis of blood and urine samples [ Time Frame: Days 1-13 and Days 26-33 (Part 1 only) sampled daily ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1, Group 1
ASP015K, low dose followed by high dose, with oral tacrolimus
Drug: Tacrolimus
Oral and Intravenous
Other Names:
  • FK506
  • Prograf
Drug: ASP015K
Oral
Experimental: Part 1, Group 2
ASP015K, high dose followed by low dose, with oral tacrolimus
Drug: Tacrolimus
Oral and Intravenous
Other Names:
  • FK506
  • Prograf
Drug: ASP015K
Oral
Experimental: Part 2
ASP015K high dose with intravenous tacrolimus
Drug: Tacrolimus
Oral and Intravenous
Other Names:
  • FK506
  • Prograf
Drug: ASP015K
Oral

Detailed Description:

This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject weighing at least 45kg and body mass index (BMI) of 18-32 kg/m2, inclusive
  • If female, 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, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
  • 12-lead ECG is normal or if abnormal, the abnormality is not clinically significant
  • Clinical laboratory test results are within normal limits or not clinically significant
  • Medically healthy, with no clinically significant medical history or abnormalities

Exclusion Criteria:

  • History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
  • Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
  • Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
  • A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
  • Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
  • History of human immunodeficiency virus (HIV) antibody
  • Positive tuberculosis (TB) skin test or Quantiferon Gold test
  • Vaccinated within the last 30 days prior to study drug administration
  • Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
  • Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
  • Absolute neutrophil count (ANC) <2500 cells/mm3
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190670

Locations
United States, Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01190670     History of Changes
Other Study ID Numbers: 015K-CL-PK16
Study First Received: August 11, 2010
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP015K
tacrolimus
healthy volunteers

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

ClinicalTrials.gov processed this record on April 16, 2014