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

NCT06952634 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ESK-001-022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (4)

Healthy Volunteer

EXPERIMENTAL

Up to 24 healthy volunteer participants will receive a single dose of ESK-001

Drug: ESK-001

Mild Hepatic Impairment

EXPERIMENTAL

8 participants with mild hepatic impairment will receive a single dose of ESK-001

Drug: ESK-001

Moderate Hepatic Impairment

EXPERIMENTAL

8 participants with moderate hepatic impairment will receive a single dose of ESK-001

Drug: ESK-001

Severe Hepatic Impairment

EXPERIMENTAL

8 participants with severe hepatic impairment will receive a single dose of ESK-001

Drug: ESK-001

Interventions

ESK-001 DRUG

Single oral dose of ESK-001 in participants from all cohorts

Healthy Volunteer; Mild Hepatic Impairment; Moderate Hepatic Impairment; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index between 18.0 and 40.0 kg/m2
• Diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (4)

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Panax Clinical Research

Miami Lakes, Florida, 33104, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Alliance for Multispecialty Research

Knoxville, Tennessee, 37920, United States

RECRUITING

Study Officials

• Jorn Drappa, Medical Director

  Alumis Inc

  STUDY DIRECTOR

Central Study Contacts

Central Contact

CONTACT

(650) 231-6625; nharada@alumis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 1, 2025
• Study Start: April 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (4)