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

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: ESK-001; Drug: Rabeprazole

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Alumis Central site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alumis Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: ESK-001-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No