A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01486017

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of three different strengths of a new tablet formulation.

Condition or Disease	Intervention/Treatment	Phase
Bioavailability of ASP015K Pharmacokinetics of ASP015K Healthy Subjects	Drug: ASP015K	Phase 1

Detailed Description

Eligible subjects will be admitted on Day-1 and remain confined on the unit for 16 days. Each subject will receive a single dose of study drug per the defined treatment periods on the mornings of Day 1, Day 6 and Day11. There will be a minimum of 5 days between each consecutive dose group. Any subject discontinuing the study prior to completion should have all end of study evaluations completed.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 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 Across Three Strengths of a New ASP015K Tablet Formulation in Healthy Volunteers

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A ASP015K oral dose low strength	Drug: ASP015K oral
Experimental: Treatment B ASP015K oral dose medium strength	Drug: ASP015K oral
Experimental: Treatment C ASP015K oral dose high strength	Drug: ASP015K oral

Arm

Intervention/Treatment

Experimental: Treatment A

ASP015K oral dose low strength

Drug: ASP015K

oral

Experimental: Treatment B

ASP015K oral dose medium strength

Drug: ASP015K

oral

Experimental: Treatment C

ASP015K oral dose high strength

Drug: ASP015K

oral

Outcome Measures

Primary Outcome Measures

Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf [Up to Day 15]

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) [Up to Day 15]
Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2 [Up to Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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