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

Alumis

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Rabeprazole; Drug: ESK-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05330858

ESK-001-002

Details and patient eligibility

About

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

Full 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.)

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

ESK-001 Liquid

Experimental group

Description:

ESK-001 administered as an oral liquid

Treatment:

Drug: ESK-001

ESK-001 Tablet Fasted

Experimental group

Description:

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

Treatment:

Drug: ESK-001

ESK-001 Tablet Fed

Experimental group

Description:

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

Treatment:

Drug: ESK-001

ESK-001 and Rabeprazole

Experimental group

Description:

ESK-001 administered as an oral tablet with rabeprazole

Treatment:

Drug: Rabeprazole

Drug: ESK-001