A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01754805

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A drug interaction study to evaluate the effect of ASP015K (twice daily) on the pharmacokinetics (PK) of once weekly oral methotrexate (MTX).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: peficitinib Drug: methotrexate	Phase 1

Detailed Description

Patients check in on day -1 and remain confined until all the exit procedures are performed on the morning of day 10. Patients to return for 1 post-treatment follow-up visit on day 13.

Patients receive a single dose of methotrexate on day 1 and day 8 and ASP015K (twice daily) on days 3 through 8 plus the morning of day 9.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis

Actual Study Start Date :

Jan 22, 2010

Actual Primary Completion Date :

Mar 25, 2010

Actual Study Completion Date :

Mar 25, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP015K and methotrexate Patients receive a single dose of methotrexate on day 1 and day 8 and ASP015K (twice daily) on days 3 through 8 plus the morning of day 9.	Drug: peficitinib oral Other Names: ASP015K Drug: methotrexate oral

Arm

Intervention/Treatment

Experimental: ASP015K and methotrexate

Patients receive a single dose of methotrexate on day 1 and day 8 and ASP015K (twice daily) on days 3 through 8 plus the morning of day 9.

Drug: peficitinib

oral

Other Names:

ASP015K

Drug: methotrexate

oral

Outcome Measures

Primary Outcome Measures

Pharmacokinetics of methotrexate (MTX): Area under the concentration-time curve from time of dosing to infinity (AUCinf) [Days 1 and 8]
Pharmacokinetics of methotrexate (MTX): Maximum concentration (Cmax) [Days 1 and 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

If female, subject must be at least 2 years post menopausal or is surgically sterile per documentation provided by a medical professional and the subject is not pregnant as documented by a negative serum pregnancy test at Screening and negative urine pregnancy test at check-in
If male, subject must agree to sexual abstinence and/or to use a highly effective method of birth control during the study period and for 60 days after the last dose of study drug
Subject must have a clinical diagnosis of Rheumatoid Arthritis (RA) at least 6 months prior to Screening
Subject must be on a stable 15 - 25 mg dose of methotrexate > 28 days prior to Screening
If subject is on a non-biologic disease modifying anti-rheumatic drug (DMARDs) therapy, the dose must be stable > 28 days prior to Screening
Subject must be willing and able to comply with the study requirements

Exclusion Criteria:

Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that would preclude participation in the study
Subject has a known history of positive test for hepatitis B surface antigen (HbsAg) or hepatitis C antibody or history of a positive test for human immunodeficiency virus (HIV) infection
Subject has received live virus vaccination within the last 30 days prior to study drug administration
Subject has a Body Mass Index (BMI) > 35 (kg/m2)
Subject is on biologic disease modifying anti-rheumatic drug (DMARDs) therapy
Subject has a current history of anemia as defined by hemoglobin of less than 12 g/dL
Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs at Screening or check-in
Subject has received any investigational agent within 30 days of screening