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This is a single-center, in-house, open-label, crossover study in 15 healthy participants.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESK-001 Liquid | Experimental | ESK-001 administered as an oral liquid |
|
| ESK-001 Tablet Fasted | Experimental | ESK-001 administered as an oral tablet in the fasted state |
|
| ESK-001 Tablet Fed | Experimental | ESK-001 administered as an oral tablet in the fed state |
|
| ESK-001 and Rabeprazole | Experimental | ESK-001 administered as an oral tablet with rabeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESK-001 | Drug | Oral tablet or liquid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax) | Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms | 18 Days |
| Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax) | Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms | 18 Days |
| Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC) | Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms | 18 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Incidence of Treatment Emergent Adverse Events of ESK-001 | Collection and review of incidence of adverse events and serious adverse events | 25 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alumis Central Site | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole | Drug | Oral Tablet |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |