Investigating ESK-001 in people with normal and impaired liver function

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

This study is testing how a new drug called ESK-001 is processed in people with healthy livers and those with different levels of liver damage to help guide future treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Alumis Inc (Industry-sponsored)
• Locations: 4 sites (Lake Forest, California and 3 other locations)
• Trial ID: NCT06952634 on ClinicalTrials.gov

What this trial studies

This phase 1, open-label, single-dose, parallel cohort study aims to evaluate the pharmacokinetics of ESK-001 in healthy volunteers and individuals with varying degrees of hepatic impairment. Participants will be categorized based on their liver function, allowing researchers to assess how the drug is processed in different populations. The study will include individuals with mild, moderate, and severe liver damage, as well as those with normal liver function, to gather comprehensive data on the drug's effects. The findings will help inform future dosing and safety considerations for patients with liver conditions.

Who should consider this trial

Good fit: Ideal candidates include adults with a body mass index between 18.0 and 40.0 kg/m2, including those with chronic hepatic impairment.

Not a fit: Patients with uncontrolled hypertension or hypotension, or those with significant comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective dosing guidelines for patients with liver impairment.

How similar studies have performed: Other studies investigating pharmacokinetics in patients with liver impairment have shown promising results, suggesting this approach is viable.

Eligibility criteria

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.

Where this trial is running

Lake Forest, California and 3 other locations

• Orange County Research Center — Lake Forest, California, United States (Recruiting)
• Panax Clinical Research — Miami Lakes, Florida, United States (Recruiting)
• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• Alliance for Multispecialty Research — Knoxville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Central Contact

Conditions Hepatic Impairment