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

Launched by ALUMIS INC · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called ESK-001 to see how it affects people with different levels of liver function. The study is looking for healthy volunteers as well as individuals who have mild, moderate, or severe liver damage. The goal is to understand how the body processes this drug in people with normal liver function compared to those with liver impairment.

To participate, you need to be between 18 and 75 years old and have a body mass index (BMI) between 18 and 40. If you have liver impairment, you should have a stable diagnosis for at least six months without significant changes in your health in the past month. Participants will receive a single dose of the study drug, and the trial is currently recruiting. It’s important to note that certain health conditions, such as uncontrolled high or low blood pressure, or significant heart or kidney issues, may exclude you from participating. If you're interested, please discuss with your healthcare provider to see if this study might be a good fit for you.

Gender

ALL

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.