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
1 other identifier
interventional
14
1 country
1
Brief Summary
This is a single-center, in-house, open-label, crossover study in 15 healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2022
CompletedFirst Submitted
Initial submission to the registry
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2022
CompletedMay 9, 2023
May 1, 2023
4 months
March 30, 2022
May 6, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
18 Days
Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
18 Days
Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
18 Days
Secondary Outcomes (1)
Assess the Incidence of Treatment Emergent Adverse Events of ESK-001
25 Days
Study Arms (4)
ESK-001 Liquid
EXPERIMENTALESK-001 administered as an oral liquid
ESK-001 Tablet Fasted
EXPERIMENTALESK-001 administered as an oral tablet in the fasted state
ESK-001 Tablet Fed
EXPERIMENTALESK-001 administered as an oral tablet in the fed state
ESK-001 and Rabeprazole
EXPERIMENTALESK-001 administered as an oral tablet with rabeprazole
Interventions
Oral tablet or liquid
Eligibility Criteria
You may qualify if:
- Healthy Men and woman age 18-60
- Able to provide written informed consent
- Females can not be pregnant or lactating
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alumis Inclead
Study Sites (1)
Alumis Central Site
Glendale, California, 91206, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2022
First Posted
April 15, 2022
Study Start
March 17, 2022
Primary Completion
June 30, 2022
Study Completion
September 20, 2022
Last Updated
May 9, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share