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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01430065

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics of ASP015K Drug Interactions Healthy Subjects	Drug: ASP015K Drug: Tacrolimus	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tacrolimus and ASP015K	Drug: ASP015K oral Drug: Tacrolimus oral Other Names: Prograf FK506

Arm

Intervention/Treatment

Experimental: Tacrolimus and ASP015K

Drug: ASP015K

oral

Drug: Tacrolimus

oral

Other Names:

Prograf

FK506

Outcome Measures

Primary Outcome Measures

Pharmacokinetic assessment of AUC through the analysis of blood and urine samples [Up to Day 13]

Secondary Outcome Measures

Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples [Up to Day 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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