Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

peficitinib

methotrexate

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring ASP015K, Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASP015K and methotrexate

Arm Description

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.

Outcomes

Primary Outcome Measures

Pharmacokinetics of methotrexate (MTX): Area under the concentration-time curve from time of dosing to infinity (AUCinf)

Pharmacokinetics of methotrexate (MTX): Maximum concentration (Cmax)

Secondary Outcome Measures

Full Information

NCT ID

NCT01754805

First Posted

December 19, 2012

Last Updated

June 6, 2019

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01754805

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

January 22, 2010 (Actual)

Primary Completion Date

March 25, 2010 (Actual)

Study Completion Date

March 25, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

ASP015K, Rheumatoid Arthritis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASP015K and methotrexate

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

peficitinib

Other Intervention Name(s)

ASP015K

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Description

oral

Primary Outcome Measure Information:

Title

Pharmacokinetics of methotrexate (MTX): Area under the concentration-time curve from time of dosing to infinity (AUCinf)

Time Frame

Days 1 and 8

Title

Pharmacokinetics of methotrexate (MTX): Maximum concentration (Cmax)

Time Frame

Days 1 and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Central Contact

Organizational Affiliation

Astellas Pharma Global Development

Official's Role

Study Chair

Facility Information:

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Citations:

PubMed Identifier

32591978

Citation

Zhu T, Moy S, Valluri U, Cao Y, Zhang W, Sawamoto T, Chindalore V, Akinlade B. Investigation of Potential Drug-Drug Interactions between Peficitinib (ASP015K) and Methotrexate in Patients with Rheumatoid Arthritis. Clin Drug Investig. 2020 Sep;40(9):827-838. doi: 10.1007/s40261-020-00937-z.

Results Reference

derived

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=325

Description

Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

We'll reach out to this number within 24 hrs