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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00920608
First received: June 12, 2009
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: AZD9056
Drug: Methotrexate
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.) [ Time Frame: During the whole study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: May 2009
Estimated Study Completion Date: September 2009
Arms Assigned Interventions
Experimental: A
AZD9056 400 mg and Methotrexate
 Drug: AZD9056
Tablets for oral use. 400 mg once daily for 7 days
Drug: Methotrexate
Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.
Other Name: Various brands used

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00920608     History of Changes
Other Study ID Numbers: D1520C00027
Study First Received: June 12, 2009
Last Updated: December 2, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
AZD9056
Pharmacokinetics
interaction
Methotrexate
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 May 16, 2013