Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants

Study Overview
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Brief Summary
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Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in 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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A Blinded, Randomized, Placebo-controlled, Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 Tablets Administered Over 14days to Healthy Participants

Conditions
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Safety and Tolerability

Intervention / Treatment
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* Drug: Experimental drug: ESK-001
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters Other inclusions as specified in the protocol Exclusion Criteria: Participant has a prior exposure to ESK-001 Participant has a history of hypersensitivity to any of the ingredients of ESK-001 Other exclusions as specified in the protocol

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: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo for ESK-001 | Other: Placebo<br>* Placebo<br>|
| Experimental: Experimental Drug ESK-001<br>Experimental Drug ESK-001 | Drug: Experimental drug: ESK-001<br>* Multiple doses of ESK-001<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | Safety and tolerability | Up to 14 days | 
| Incidence of Serious Adverse Events (SAEs) | Safety and tolerability | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14 | Pharmacokinetics | Up to 14 days | 
| The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14 | Pharmacokinetics | Up to 14 days | 
| The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14. | Pharmacokinetics | Up to 14 days | 
| The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14. | Pharmacokinetics | Up to 14 days | 
| Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14 | Pharmacokinetics | Up to 14 days | 
| Apparent clearance CL(Clearance)/F for ESK001 on Day 1 | Pharmacokinetics | Up to 14 days | 
| The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14 | Pharmacokinetics | Up to 14 days | 
| The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14. | Pharmacokinetics | Up to 14 days | 
| Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001 | Pharmacodynamics | 14 days after first dose |