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A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AZD9056
Methotrexate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring AZD9056, Pharmacokinetics, interaction, Methotrexate, Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with rheumatoid arthritis
  • Currently on Methotrexate treatment
  • Provision of informed consent

Exclusion Criteria:

  • History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry)
  • Patients who were taking prescription of medications listed below:

Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin

  • Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    AZD9056 400 mg and Methotrexate

    Outcomes

    Primary Outcome Measures

    Pharmacokinetics of AZD9056 and Methotrexate

    Secondary Outcome Measures

    Pharmacokinetics of AZD9056 and 7-OH Methotrexate
    Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)

    Full Information

    First Posted
    June 12, 2009
    Last Updated
    December 2, 2010
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00920608
    Brief Title
    A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
    Official Title
    A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    AZD9056, Pharmacokinetics, interaction, Methotrexate, Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    AZD9056 400 mg and Methotrexate
    Intervention Type
    Drug
    Intervention Name(s)
    AZD9056
    Intervention Description
    Tablets for oral use. 400 mg once daily for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Methotrexate
    Other Intervention Name(s)
    Various brands used
    Intervention Description
    Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.
    Primary Outcome Measure Information:
    Title
    Pharmacokinetics of AZD9056 and Methotrexate
    Time Frame
    Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetics of AZD9056 and 7-OH Methotrexate
    Time Frame
    Pharmacokinetics samples for 7-OH Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
    Title
    Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)
    Time Frame
    During the whole study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with rheumatoid arthritis Currently on Methotrexate treatment Provision of informed consent Exclusion Criteria: History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry) Patients who were taking prescription of medications listed below: Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

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