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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484964
• Other study ID #: 015K-CL-PK19
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2011
• Last updated: December 1, 2011
• Start date: September 2011
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioavailability of ASP015K
• Healthy Subjects
• Pharmacokinetics of ASP015K

Intervention

Drug:
• ASP015K
oral

Locations

Country	Name	City	State
United States	PAREXEL	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf		Up to Day 18	No
Secondary	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	No
Secondary	Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2		Up to Day 18	No