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

Phase 1

Withdrawn

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AZD9056; Drug: Methotrexate

• Registration Number: NCT00920608
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Study Completion: 2009-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients diagnosed with rheumatoid arthritis
• Currently on Methotrexate treatment
• Provision of informed consent

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	AZD9056	AZD9056 400 mg and Methotrexate
A	Methotrexate	AZD9056 400 mg and Methotrexate

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of AZD9056 and Methotrexate	Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of AZD9056 and 7-OH Methotrexate	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.)	During the whole study