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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05330858

Enrollment

Registered

2022-04-15

Start date

2022-03-17

Completion date

2022-09-20

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

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.)

Interventions

DRUGESK-001

Oral tablet or liquid

DRUGRabeprazole

Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026