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
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis focused on measuring ASP015K, Rheumatoid Arthritis
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
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
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
No
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
No
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
No
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
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