---
title: A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
nct_id: NCT00920608
overall_status: WITHDRAWN
phase: PHASE1
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Rheumatoid Arthritis
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00920608.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00920608"
ct_last_update_post_date: 2010-12-03
last_seen_at: "2026-05-12T06:47:59.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

**Official Title:** 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

**NCT ID:** [NCT00920608](https://clinicaltrials.gov/study/NCT00920608)

## Key Facts

- **Status:** WITHDRAWN
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** AstraZeneca
- **Conditions:** Rheumatoid Arthritis
- **Start Date:** 2009-05
- **Completion Date:** 2009-09
- **CT.gov Last Update:** 2010-12-03

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **A** (EXPERIMENTAL) — AZD9056 400 mg and Methotrexate

## Interventions

- **AZD9056** (DRUG) — Tablets for oral use. 400 mg once daily for 7 days
- **Methotrexate** (DRUG) — Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.

## 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)_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00920608.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00920608*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*