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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00920608
• Other study ID #: D1520C00027
• Status: Withdrawn
• Phase: Phase 1
• First received: June 12, 2009
• Last updated: December 2, 2010
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 12
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AZD9056
Tablets for oral use. 400 mg once daily for 7 days
• Methotrexate
Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)		During the whole study	Yes