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

Phase 1WithdrawnNCT00920608

AstraZeneca12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

AZD9056DRUG

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

MethotrexateDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)

Time frame: During the whole study

Data from ClinicalTrials.gov

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