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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: ESK-001; Drug: Rabeprazole

• Registration Number: NCT05330858
• Lead Sponsor: Alumis Inc

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2022-03-17
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-06
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Healthy Men and woman age 18-60
• Able to provide written informed consent
• Females can not be pregnant or lactating

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ESK-001 and Rabeprazole	ESK-001	ESK-001 administered as an oral tablet with rabeprazole
ESK-001 Tablet Fasted	ESK-001	ESK-001 administered as an oral tablet in the fasted state
ESK-001 Tablet Fed	ESK-001	ESK-001 administered as an oral tablet in the fed state
ESK-001 and Rabeprazole	Rabeprazole	ESK-001 administered as an oral tablet with rabeprazole
ESK-001 Liquid	ESK-001	ESK-001 administered as an oral liquid

Primary Outcome Measures

Name	Time	Method
Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)	18 Days	Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax)	18 Days	Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC)	18 Days	Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms

Secondary Outcome Measures

Name	Time	Method
Assess the Incidence of Treatment Emergent Adverse Events of ESK-001	25 Days	Collection and review of incidence of adverse events and serious adverse events

Trial Locations

Locations (1)

Alumis Central Site; 🇺🇸 Glendale, California, United States