An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

A Phase 1, Open Label, Single Dose Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of ESK001

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: envudeucitinib

Detailed 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.)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
  • Florida
    • Miami Lakes, Florida, United States, 33104
      • Panax Clinical Research
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria for All Participants:

• Body mass index between 18.0 and 40.0 kg/m2

Key Inclusion Criteria for Participants with Hepatic Impairment:

• Diagnosis of chronic (> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history

Key Exclusion Criteria for All Participants:

• Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg), or resting pulse rate < 45 or > 100 bpm. Measurements may be repeated once in order to determine eligibility

Key Exclusion Criteria for Healthy Volunteer:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
• Positive hepatitis panel and/or positive human immunodeficiency virus test.

Key Exclusion Criteria for Participants with Hepatic Impairment:

• History of any uncontrolled or unstable renal, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.
• History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
• Liver function tests outside the appropriate reference ranges that are not consistent with hepatic dysfunction, as determined by the investigator or designee.
• QTcF > 480 ms for males or > 490 ms for females at screening or check-in, as confirmed from the mean of the original value and 2 repeats.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteer; Up to 24 healthy volunteer participants will receive a single dose of ESK-001	Drug: envudeucitinib; Single oral dose of ESK-001 in participants from all cohorts
Experimental: Mild Hepatic Impairment; 8 participants with mild hepatic impairment will receive a single dose of ESK-001	Drug: envudeucitinib; Single oral dose of ESK-001 in participants from all cohorts
Experimental: Moderate Hepatic Impairment; 8 participants with moderate hepatic impairment will receive a single dose of ESK-001	Drug: envudeucitinib; Single oral dose of ESK-001 in participants from all cohorts
Experimental: Severe Hepatic Impairment; 8 participants with severe hepatic impairment will receive a single dose of ESK-001	Drug: envudeucitinib; Single oral dose of ESK-001 in participants from all cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	48 hours
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]	48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation	48 hours
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations	48 hours

Collaborators and Investigators

• Sponsor: Alumis Inc
• Investigators: Study Director: Jorn Drappa, Medical Director, Alumis Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Actual): March 24, 2026
• Study Completion (Actual): March 24, 2026

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ESK-001-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No