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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Bioavailability of ASP015K; Pharmacokinetics of ASP015K
• Intervention / Treatment: Drug: ASP015K

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf	Up to Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 2, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; healthy subjects; transplantation; bioavailability; psoriasis; ASP015K
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Peficitinib
• Other Study ID Numbers: 015K-CL-PK18