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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01754805
First received: December 19, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: ASP015K
Drug: Methotrexate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetics of methotrexate (MTX): Area under the concentration-time curve from time of dosing to infinity (AUCinf) [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of methotrexate (MTX): Maximum concentration (Cmax) [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP015K and methotrexate Drug: ASP015K
oral
Drug: Methotrexate
oral

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754805

Locations
United States, Alabama
Anniston, Alabama, United States, 36207
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01754805     History of Changes
Other Study ID Numbers: 015K-CL-PK13
Study First Received: December 19, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP015K
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014