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

NCT01929577 | Completed Phase 1

• 1 other identifier: 015K-CL-PK09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ASP015K; healthy subjects

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameter of ASP015K: Cmax

  Maximum Concentration (Cmax)

  Day 1-4 of each treatment period

• Pharmacokinetic parameter of ASP015K: AUClast

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

  Day 1-4 of each treatment period

• Pharmacokinetic parameter of ASP015K: AUCinf

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

  Day 1-4 of each treatment period

Secondary Outcomes (3)

• Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2

  Day 1-4 of each treatment period

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

  Day 1-4 of each treatment period

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

  Up to Day 4 in each treatment period

Study Arms (3)

ASP015K Test Tablet - Fasting Conditions

EXPERIMENTAL

ASP015K administered as a single tablet under fasting conditions.

Drug: ASP015K

ASP015K Reference Tablet - Fasting Conditions

EXPERIMENTAL

ASP015K administered via multiple tablets under fasting conditions

Drug: ASP015K

ASP015K Test Tablet -Fed Conditions

EXPERIMENTAL

ASP015K administered as a single tablet under fed conditions

Drug: ASP015K

Interventions

ASP015K DRUG

oral tablet

ASP015K Reference Tablet - Fasting Conditions; ASP015K Test Tablet - Fasting Conditions; ASP015K Test Tablet -Fed Conditions

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (1)

Parexel - Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

peficitinib

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

US (1)