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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01484964

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

24.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf [Up to Day 18]

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 18]
Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2 [Up to Day 18]

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
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