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| ID | Type | Description | Link |
|---|---|---|---|
| AF219-023 | Other Identifier | Afferent Pharmaceuticals |
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The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK of three gefapixant formulations; and, to assess the safety and tolerability of gefapixant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefapixant + Omeprazole | Experimental | Gefapixant oral tablets (15mg and 30 mg) administered twice daily for 15 days + Omeprazole oral capsules (20 mg or 40 mg) administered once or twice daily for 10 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 20 mg oral capsules administered once daily for 10 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) profiles of three different oral formulations of gefapixant | Plasma gefapixant concentration versus time profiles will be plotted for each subject; similar summary plots will be constructed for each treatment period. Plasma gefapixant PK parameters will be calculated using noncompartmental methods and summarized using descriptive statistics by each treatment. | 12 hours |
| Maximum plasma concentration (Cmax) profile of gefapixant following administration of Omeprazole | Analysis of variance (ANOVA) will be performed on log normal-transformed Cmax and AUC0-t values to determine the extent of a drug interaction, if any, of Omeprazole on the plasma gefapixant PK parameters | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Armas, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| C000597312 | Gefapixant |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Omeprazole | Drug | 40 mg oral capsules administered twice daily for 10 days |
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| Gefapixant | Drug | Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days |
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| Gefapixant | Drug | Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |