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A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

NCT ID: NCT01190670

Last Updated: 2010-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Pharmacokinetics of ASP015K and Tacrolimus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Part 1, Group 1

ASP015K, low dose followed by high dose, with oral tacrolimus

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Oral and Intravenous

ASP015K

Intervention Type DRUG

Oral

Part 1, Group 2

ASP015K, high dose followed by low dose, with oral tacrolimus

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Oral and Intravenous

ASP015K

Intervention Type DRUG

Oral

Part 2

ASP015K high dose with intravenous tacrolimus

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Oral and Intravenous

ASP015K

Intervention Type DRUG

Oral

Interventions

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Tacrolimus

Oral and Intravenous

Intervention Type DRUG

ASP015K

Oral

Intervention Type DRUG

Other Intervention Names

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FK506 Prograf

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Global Development

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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015K-CL-PK16

Identifier Type: -

Identifier Source: org_study_id