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

NCT01486017 | Completed Phase 1

• 1 other identifier: 015K-CL-PK18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability of ASP015K; Pharmacokinetics of ASP015K; Healthy Subjects

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf

  Up to Day 15

Secondary Outcomes (2)

• 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

Study Arms (3)

Treatment A

EXPERIMENTAL

ASP015K oral dose low strength

Drug: ASP015K

Treatment B

EXPERIMENTAL

ASP015K oral dose medium strength

Drug: ASP015K

Treatment C

EXPERIMENTAL

ASP015K oral dose high strength

Drug: ASP015K

Interventions

ASP015K DRUG

oral

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Covance

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Psoriasis

Interventions

peficitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 6, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

US (1)