Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants

Study Overview
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Brief Summary
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This is a single-center, in-house, open-label, crossover study in 15 healthy participants.

Detailed Description
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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.)

Official Title
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The Relative Bioavailability of an ESK-001 Tablet Versus Liquid Formulation, and the Effect of Food or Gastric Acid Reduction on the Pharmacokinetics of ESK-001 in Healthy Participants

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: ESK-001
* Drug: Rabeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Men and woman age 18-60 Able to provide written informed consent Females can not be pregnant or lactating Exclusion Criteria: Prior exposure to ESK-001 History of malignancy within the last 10 years Positive for HIV, Hepatitis B or C History of tuberculosis Positive test for alcohol or drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESK-001 Liquid<br>ESK-001 administered as an oral liquid | Drug: ESK-001<br>* Oral tablet or liquid<br>|
| Experimental: ESK-001 Tablet Fasted<br>ESK-001 administered as an oral tablet in the fasted state | Drug: ESK-001<br>* Oral tablet or liquid<br>|
| Experimental: ESK-001 Tablet Fed<br>ESK-001 administered as an oral tablet in the fed state | Drug: ESK-001<br>* Oral tablet or liquid<br>|
| Experimental: ESK-001 and Rabeprazole<br>ESK-001 administered as an oral tablet with rabeprazole | Drug: ESK-001<br>* Oral tablet or liquid<br>Drug: Rabeprazole<br>* Oral Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |