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ESK-001 Tablet Fasted for Pharmacokinetics

Phase 1
Waitlist Available
Research Sponsored by Alumis Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 days
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC)
Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax)
Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)
Secondary study objectives
Assess the Incidence of Treatment Emergent Adverse Events of ESK-001

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Group I: ESK-001 and RabeprazoleExperimental Treatment2 Interventions
ESK-001 administered as an oral tablet with rabeprazole
Group II: ESK-001 Tablet FedExperimental Treatment1 Intervention
ESK-001 administered as an oral tablet in the fed state
Group III: ESK-001 Tablet FastedExperimental Treatment1 Intervention
ESK-001 administered as an oral tablet in the fasted state
Group IV: ESK-001 LiquidExperimental Treatment1 Intervention
ESK-001 administered as an oral liquid
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rabeprazole
FDA approved
ESK-001
2022
Completed Phase 2
~250

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alumis IncLead Sponsor
7 Previous Clinical Trials
2,546 Total Patients Enrolled
~4 spots leftby Nov 2025
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