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CompletedNCT01190670Updated Oct 14, 2010

A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

A Phase 1 interventional study of Tacrolimus and ASP015K in Healthy and Pharmacokinetics of ASP015K and Tacrolimus, sponsored by Astellas Pharma Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-14.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy
  • Pharmacokinetics of ASP015K and Tacrolimus

Keywords

  • ASP015K
  • tacrolimus
  • healthy volunteers
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Part 1, Group 1

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

    Drug: Tacrolimus · Drug: ASP015K

  • Experimental
    Part 1, Group 2

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

    Drug: Tacrolimus · Drug: ASP015K

  • Experimental
    Part 2

    ASP015K high dose with intravenous tacrolimus

    Drug: Tacrolimus · Drug: ASP015K

Interventions

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic variables assessment through analysis of blood and urine samples

    Time frame: Days 1-13 and Days 26-33 (Part 1 only) sampled daily

07

Study locations

1 site
  • Honolulu, Hawaii 96813, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2010, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2010
First posted
Aug 30, 2010
Start
Jul 2010
Primary completionActual
Sep 2010
CompletionActual
Sep 2010
Last update
Oct 14, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01190670
First posted
Aug 30, 2010
Start date
Jul 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Oct 14, 2010

Study contacts

Use Central Contact
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Tacrolimus · Peficitinib

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