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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014