An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
NCT06952634 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-05-12
Summary
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
Conditions
- Hepatic Impairment
Interventions
- DRUG
-
envudeucitinib
Single oral dose of ESK-001 in participants from all cohorts
Sponsors & Collaborators
-
Alumis Inc
lead INDUSTRY
Principal Investigators
-
Jorn Drappa, Medical Director · Alumis Inc
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-29
- Primary Completion
- 2026-03-24
- Completion
- 2026-03-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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