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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00920608

First received: June 12, 2009

Last updated: December 2, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 12, 2009
Last Updated Date	December 2, 2010
Start Date ^ICMJE	May 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 12, 2009)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00920608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 12, 2009)	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 ] [ Designated as safety issue: No ] Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.) [ Time Frame: During the whole study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: AZD9056 Tablets for oral use. 400 mg once daily for 7 days Drug: Methotrexate Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3. Other Name: Various brands used
Study Arm (s)	Experimental: A AZD9056 400 mg and Methotrexate Interventions: Drug: AZD9056 Drug: Methotrexate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	12
Estimated Completion Date	September 2009
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00920608
Other Study ID Numbers ^ICMJE	D1520C00027
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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