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

Alumis Inc14 enrolled

Overview

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.)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

ESK-001DRUG

Oral tablet or liquid

RabeprazoleDRUG

Oral Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Alumis Central Site

Glendale, California, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 18 Days

Secondary Outcomes

Assess the Incidence of Treatment Emergent Adverse Events of ESK-001

Collection and review of incidence of adverse events and serious adverse events

Time frame: 25 Days

Data from ClinicalTrials.gov

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