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CompletedNCT01929577Updated Sep 16, 2013

A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects

A Phase 1 interventional study of ASP015K in Bioavailability of ASP015K, Healthy Subjects and Pharmacokinetics of ASP015K, sponsored by Astellas Pharma Global Development, 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 2013-09-16.

Sponsored by Astellas Pharma Global Development, Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.

02

Conditions studied

  • Bioavailability of ASP015K
  • Healthy Subjects
  • Pharmacokinetics of ASP015K
  • Food Effect of ASP015K

Keywords

  • ASP015K
  • healthy subjects
03

In context

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) 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

Inclusion criteria

  • Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses prior to screening], or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).
  • Female subject must have a negative pregnancy test at screening and day -1 of treatment period 1.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
  • Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
  • Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after final study drug administration.
  • Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.

Exclusion criteria

Exclusion Criteria:

  • Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
  • Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
  • Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check-in.
  • Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), intermittent acetaminophen (to a maximum of 2 g/day).
  • Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to screening.
  • Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) prior to day -1 of treatment period 1.
  • Subject has had 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 check-in on day -1 of treatment period 1.
  • Subject has a positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (HAV) (Immunoglobulin [Ig] M), anti-hepatitis C virus (HCV), hepatitis B core antibody, or anti-human immunodeficiency virus (HIV) type 1 or type 2 at screening.
  • Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT® test at screening.
  • Subject received any vaccine within 60 days prior to study drug administration.
  • Subject has an absolute neutrophil count (ANC) \< 2000 cells/mm3 or a creatine phosphokinase (CPK) > 1.5 x ULN at screening or day -1 of treatment period 1.
  • Subject has had major gastrointestinal (GI) surgery or has a medical condition, which may inhibit the absorption and/or metabolism of study drug.
05

Study design

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

Study arms

  • Experimental
    ASP015K Test Tablet - Fasting Conditions

    ASP015K administered as a single tablet under fasting conditions.

    Drug: ASP015K

  • Experimental
    ASP015K Reference Tablet - Fasting Conditions

    ASP015K administered via multiple tablets under fasting conditions

    Drug: ASP015K

  • Experimental
    ASP015K Test Tablet -Fed Conditions

    ASP015K administered as a single tablet under fed conditions

    Drug: ASP015K

Interventions

  • DrugASP015K

    oral tablet

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameter of ASP015K: Cmax

    Maximum Concentration (Cmax)

    Time frame: Day 1-4 of each treatment period

  2. Pharmacokinetic parameter of ASP015K: AUClast

    Area Under the Curve from time zero to the last measurable time (AUClast)

    Time frame: Day 1-4 of each treatment period

  3. Pharmacokinetic parameter of ASP015K: AUCinf

    Area Under the Curve from time zero extrapolated to infinity (AUCinf)

    Time frame: Day 1-4 of each treatment period

Secondary outcomes

  1. Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2

    Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)

    Time frame: Day 1-4 of each treatment period

  2. Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2

    Time frame: Day 1-4 of each treatment period

  3. Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements

    Time frame: Up to Day 4 in each treatment period

07

Study locations

1 site
  • Parexel - Early Phase Clinical Unit
    Baltimore, Maryland 21225, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01929577
Lead sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Janssen Biotech, Inc.
Responsible party
Sponsor
First posted
Aug 28, 2013
Start date
May 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Sep 16, 2013

Study contacts

Medical Director
study director · Astellas Pharma Global Development, Inc.

Oversight

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

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This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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