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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00920608

Enrollment

Registered

2009-06-15

Start date

2009-05-31

Completion date

2009-09-30

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

AZD9056, Pharmacokinetics, interaction, Methotrexate, Rheumatoid Arthritis

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.

Interventions

DRUGAZD9056

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

DRUGMethotrexate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026