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OpenTrials
Completed

NCT Number: NCT05330858

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

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

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Key information

Conditions

Pharmacokinetics

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alumis Central Site

Glendale, California, 91206, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESK-001

Drug

Oral tablet or liquid

rabeprazole

Drug

Oral Tablet

Primary outcomes

  1. Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)

    Time frame: 18 Days

    Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms

  2. Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax)

    Time frame: 18 Days

    Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms

  3. Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC)

    Time frame: 18 Days

    Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms

Secondary outcomes

  1. Assess the Incidence of Treatment Emergent Adverse Events of ESK-001

    Time frame: 25 Days

    Collection and review of incidence of adverse events and serious adverse events

Sponsors and collaborators

Lead sponsor

Alumis Inc

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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