NCT00920608

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 rheumatoid-arthritis

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

First QC Date

June 12, 2009

Last Update Submit

December 2, 2010

Conditions

Rheumatoid Arthritis

Keywords

AZD9056PharmacokineticsinteractionMethotrexateRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

A

EXPERIMENTAL

AZD9056 400 mg and Methotrexate

Drug: AZD9056Drug: Methotrexate

Interventions

AZD9056DRUG

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

A
MethotrexateDRUG

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

Also known as: Various brands used
A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

AZD9056Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

May 1, 2009

Study Completion

September 1, 2009

Last Updated

December 3, 2010

Record last verified: 2010-12