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

October 17, 2024 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. 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
  3. Subject must have a clinical diagnosis of Rheumatoid Arthritis (RA) at least 6 months prior to Screening
  4. Subject must be on a stable 15 - 25 mg dose of methotrexate > 28 days prior to Screening
  5. If subject is on a non-biologic disease modifying anti-rheumatic drug (DMARDs) therapy, the dose must be stable > 28 days prior to Screening
  6. Subject must be willing and able to comply with the study requirements

Exclusion Criteria:

  1. 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
  2. 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
  3. Subject has received live virus vaccination within the last 30 days prior to study drug administration
  4. Subject has a Body Mass Index (BMI) > 35 (kg/m2)
  5. Subject is on biologic disease modifying anti-rheumatic drug (DMARDs) therapy
  6. Subject has a current history of anemia as defined by hemoglobin of less than 12 g/dL
  7. 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
  8. Subject has received any investigational agent within 30 days of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Chair: Central Contact, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2010

Primary Completion (Actual)

March 25, 2010

Study Completion (Actual)

March 25, 2010

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimated)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015K-CL-PK13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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