Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929577
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : September 16, 2013
Sponsor:
Collaborator:
Janssen Biotech, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Bioavailability of ASP015K Healthy Subjects Pharmacokinetics of ASP015K Food Effect of ASP015K Drug: ASP015K Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: ASP015K Test Tablet - Fasting Conditions
ASP015K administered as a single tablet under fasting conditions.
Drug: ASP015K
oral tablet

Experimental: ASP015K Reference Tablet - Fasting Conditions
ASP015K administered via multiple tablets under fasting conditions
Drug: ASP015K
oral tablet

Experimental: ASP015K Test Tablet -Fed Conditions
ASP015K administered as a single tablet under fed conditions
Drug: ASP015K
oral tablet




Primary Outcome Measures :
  1. Pharmacokinetic parameter of ASP015K: Cmax [ Time Frame: Day 1-4 of each treatment period ]
    Maximum Concentration (Cmax)

  2. Pharmacokinetic parameter of ASP015K: AUClast [ Time Frame: Day 1-4 of each treatment period ]
    Area Under the Curve from time zero to the last measurable time (AUClast)

  3. Pharmacokinetic parameter of ASP015K: AUCinf [ Time Frame: Day 1-4 of each treatment period ]
    Area Under the Curve from time zero extrapolated to infinity (AUCinf)


Secondary Outcome Measures :
  1. Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2 [ Time Frame: Day 1-4 of each treatment period ]
    Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)

  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929577


Locations
Layout table for location information
United States, Maryland
Parexel - Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Janssen Biotech, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Global Development, Inc.
Layout table for additonal information
Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT01929577    
Other Study ID Numbers: 015K-CL-PK09
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
ASP015K
healthy subjects
Additional relevant MeSH terms:
Layout table for MeSH terms
Peficitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs