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

NCT ID: NCT01486017

Last Updated: 2011-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-09-30

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.

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.

Conditions

Bioavailability of ASP015K; Pharmacokinetics of ASP015K; Healthy Subjects

Keywords

ASP015K; healthy subjects; bioavailability; rheumatoid arthritis; psoriasis; transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment A

ASP015K oral dose low strength

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Treatment B

ASP015K oral dose medium strength

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Treatment C

ASP015K oral dose high strength

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Interventions

ASP015K

oral

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Covance

Dallas, Texas, United States

Countries

United States

Other Identifiers

015K-CL-PK18

Identifier Type: -

Identifier Source: org_study_id