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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05330858
• Other study ID #: ESK-001-002
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: May 2023
• Source: Alumis Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 20, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• ESK-001
Oral tablet or liquid
• Rabeprazole
Oral Tablet

Locations

Country	Name	City	State
United States	Alumis Central Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Alumis Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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