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

NCT ID: NCT00920608

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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AZD9056 Pharmacokinetics interaction Methotrexate Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

AZD9056 400 mg and Methotrexate

Group Type EXPERIMENTAL

AZD9056

Intervention Type DRUG

Tablets for oral use. 400 mg once daily for 7 days

Methotrexate

Intervention Type DRUG

Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.

Interventions

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AZD9056

Tablets for oral use. 400 mg once daily for 7 days

Intervention Type DRUG

Methotrexate

Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.

Intervention Type DRUG

Other Intervention Names

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Various brands used

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Other Identifiers

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D1520C00027

Identifier Type: -

Identifier Source: org_study_id