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

NCT01754805 | Completed Phase 1

• 1 other identifier: 015K-CL-PK13
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

ASP015K; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

ASP015K and methotrexate

EXPERIMENTAL

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; Drug: methotrexate

Interventions

peficitinib DRUG

oral

Also known as: ASP015K

ASP015K and methotrexate

methotrexate DRUG

oral

ASP015K and methotrexate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Anniston, Alabama, 36207, United States

Location

Related Publications (1)

• 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.

  PMID: 32591978 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

peficitinib; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Central Contact

  Astellas Pharma Global Development

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 21, 2012
• Study Start: January 22, 2010
• Primary Completion: March 25, 2010
• Study Completion: March 25, 2010
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)