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Completed

NCT Number: NCT01430065

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

This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.

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Key information

Conditions

Pharmacokinetics of ASP015K Drug Interactions Healthy Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP015K

Drug

oral

Tacrolimus

Drug

oral

Other names: Prograf, FK506

Primary outcomes

  1. Pharmacokinetic assessment of AUC through the analysis of blood and urine samples

    Time frame: Up to Day 13

Secondary outcomes

  1. Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples

    Time frame: Up to Day 13

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 7, 2011
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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