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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2022-09-20

Brief Summary

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

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Detailed Description

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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.)

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ESK-001 Liquid

ESK-001 administered as an oral liquid

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet or liquid

ESK-001 Tablet Fasted

ESK-001 administered as an oral tablet in the fasted state

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet or liquid

ESK-001 Tablet Fed

ESK-001 administered as an oral tablet in the fed state

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet or liquid

ESK-001 and Rabeprazole

ESK-001 administered as an oral tablet with rabeprazole

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet or liquid

Rabeprazole

Intervention Type DRUG

Oral Tablet

Interventions

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ESK-001

Oral tablet or liquid

Intervention Type DRUG

Rabeprazole

Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes