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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This study has been withdrawn prior to enrollment.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

June 12, 2009
December 2, 2010
May 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00920608 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Rheumatoid Arthritis
  • 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
Experimental: A
AZD9056 400 mg and Methotrexate
Interventions:
  • Drug: AZD9056
  • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
12
September 2009
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00920608
D1520C00027
No
Not Provided
AstraZeneca
Not Provided
Not Provided
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP