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

Sponsor

Alumis Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05330858

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Days)

30.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: ESK-001 Drug: Rabeprazole	Phase 1

Detailed Description

This is a single-center, in-house, open-label, 4-period, partly randomized crossover study in 15 healthy participants. Each participant will receive a single ESK-001 dose on 4 occasions. Eligible participants will be admitted to the clinical research unit (CRU) on the day prior to the first study drug administration (Day 1, Period 1) and remain in the CRU for 18 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Mar 17, 2022

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alumis Central Site	Glendale	California	United States	91206

Sponsors and Collaborators

Alumis Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alumis Inc

ClinicalTrials.gov Identifier:

NCT05330858

Other Study ID Numbers:

ESK-001-002

First Posted:

Apr 15, 2022

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rabeprazole

Study Results

No Results Posted as of Apr 15, 2022