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| ID | Type | Description | Link |
|---|---|---|---|
| Inflammation | Other Identifier | Amgen |
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Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 357 | Experimental | AMG 357 is a small molecule for treatment of inflammatory disease |
|
| Placebo | Placebo Comparator | Matching placebo to AMG 357 containing no active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 357 | Drug | Oral administration available in varying dose strength. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects. | up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics | Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects | up to 35 days |
| Effect of Food on AMG 357 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Christchurch | 8011 | New Zealand | |||
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| Placebo |
| Drug |
Matching placebo to AMG 357 containing no active drug |
|
To assess the effect of food on the PK parameters of AMG 357
| up to 11 days |
| Christchurch |
| New Zealand |
| Research Site | Grafton, Auckland | 1010 | New Zealand |