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

NCT01484964 | Completed Phase 1

• 1 other identifier: 015K-CL-PK19
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics of ASP015K; Bioavailability of ASP015K; Healthy Subjects

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf

  Up to Day 18

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 18

• Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2

  Up to Day 18

Study Arms (3)

Treatment A

EXPERIMENTAL

ASP015K Formulation 1 with moderate-fat meal

Drug: ASP015K

Treatment B

EXPERIMENTAL

ASP015K Formulation 2 under fasting conditions

Drug: ASP015K

Treatment C

EXPERIMENTAL

ASP015K Formulation 2 with moderate-fat meal

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
• Subject is willing to take and complete the moderate-fat breakfast within 30 minutes

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)

PAREXEL

Glendale, California, 91206, 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 Monitor

  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 5, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 5, 2011

Record last verified: 2011-12

Locations

US (1)