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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | AZD9056 400 mg and Methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9056 | Drug | Tablets for oral use. 400 mg once daily for 7 days |
| |
| Measure | Description | 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 |
| Measure | Description | 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.) |
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Inclusion Criteria:
Exclusion Criteria:
Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000608601 | AZD9056 |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate |
| Drug |
Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3. |
|
|
| During the whole study |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |