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

AstraZeneca

Status and phase: Withdrawn; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: AZD9056; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920608

D1520C00027

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

A

Experimental group

Description:

AZD9056 400 mg and Methotrexate

Treatment:

Drug: AZD9056

Drug: Methotrexate