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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430065

Enrollment

Registered

2011-09-07

Start date

2009-06-30

Completion date

2009-06-30

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interactions, Healthy Subjects, Pharmacokinetics of ASP015K

Keywords

transplant, ASP015K, tacrolimus, Prograf, healthy volunteers

Brief summary

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

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.

Interventions

DRUGASP015K

oral

DRUGTacrolimus

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic assessment of AUC through the analysis of blood and urine samples	Up to Day 13

Secondary

Measure	Time frame
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples	Up to Day 13

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026