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The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 853 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 853 | Drug | Single dose administration of AMG 853 or placebo in tablet form to adolescent and adult subjects with asthma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability | Throughout the study duration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (including Cmax and AUC) for a single dose administration of AMG 853 in adolescent and adult subjects | Throughout study duration (at predose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 168 hours after dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C573852 | vidupiprant |
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| Placebo | Drug | Placebo to AMG 853 |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |