A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation - Full Text View

Purpose

The purpose of this study is to determine the bioavailability and pharmacokinetics between two different formulations of ASP015K tablets and determine the food effect on the absorption of the new formulation.

Condition	Intervention	Phase
Pharmacokinetics of ASP015K Bioavailability of ASP015K Healthy Subjects	Drug: ASP015K	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Phase I, Single-Dose, Open-Label, Three-Period, Randomized, Crossover Study to Compare the Relative Bioavailability Between Two Tablet Formulations of ASP015K and to Assess the Food Effect on a New Formulation in Healthy Volunteers

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf [ Time Frame: Up to Day 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite of pharmacokinetic parameters of ASP015K: tmax, apparent terminal elimination half-life (t1/2), apparent body clearance after oral dosing (CL/F), and apparent volume of distribution (Vz/F) [ Time Frame: Up to Day 18 ] [ Designated as safety issue: No ]
Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2 [ Time Frame: Up to Day 18 ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	September 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment A ASP015K Formulation 1 with moderate-fat meal	Drug: ASP015K oral
Experimental: Treatment B ASP015K Formulation 2 under fasting conditions	Drug: ASP015K oral
Experimental: Treatment C ASP015K Formulation 2 with moderate-fat meal	Drug: ASP015K oral

Detailed Description:

Eligible subjects will be admitted on Day -2 and remain confined on the unit for 20 days. Each subject will receive a single dose of study drug per the defined treatment periods on the morning of Day 1, Day 8 and Day 15. There will be a minimum of 7 days between each consecutive dose group.

For Treatment A, Formulation 1 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast. Treatment B, Formulation 2 tablets will be administered in a fasted state. For Treatment C, Formulation 2 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast.

Any subject discontinuing the study prior to completion should have all end of study evaluations completed

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject weighs at least 45 kg and has a body mass index (BMI) of 18-32 kg/m2
Male subject agrees to sexual abstinence, is surgically sterile or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method until 90 days after the last dose of study drug administration
Male subject agrees to not donate sperm until 90 days after the dose of study drug administration
Female subject is surgically sterile or is post-menopausal and is not pregnant and is not lactating
Subject's 12-lead electrocardiogram (ECG) is normal
Subject must be capable of swallowing multiple tablets
Subject is willing to take and complete the moderate-fat breakfast within 30 minutes

Exclusion Criteria:

Subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition
Subject has had major GI surgery (such as colectomy, cholecystectomy, etc)
Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years
Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week
Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody
Subject has a history of the human immunodeficiency virus (HIV) antibody
Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test
Subject received any vaccine within 60 days
Subject received an experimental agent within 30 days
Subject has an absolute neutrophil count (ANC) < 2500 cells/mm3
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
Subject has a history of smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484964

Locations

United States, California
PAREXEL
Glendale, California, United States, 91206

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Medical Monitor

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01484964 History of Changes
Other Study ID Numbers:	015K-CL-PK19
Study First Received:	December 1, 2011
Last Updated:	December 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

ASP015K
healthy subjects
bioavailability
food effect

rheumatoid arthritis
psoriasis
transplantation

ClinicalTrials.gov processed this record on May 16, 2013