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

Launched by ALUMIS INC · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ESK-001 to understand how it is processed in the body, specifically in people with different levels of kidney health. It includes healthy volunteers as well as participants who have mild, moderate, or severe kidney impairment. The goal is to learn how the drug behaves in individuals with normal kidney function compared to those with kidney issues, which can help ensure safety and effectiveness.

To be eligible for this trial, participants should be between 18 and 80 years old and have a body mass index (BMI) between 18.0 and 40.0 kg/m². Those with kidney impairment must have a stable kidney condition and not require dialysis. Participants can expect to take a single dose of the study drug and undergo monitoring to assess how their body handles it. Importantly, individuals with certain medical histories or conditions, such as recent significant health issues or certain surgeries, may not be able to participate. The trial is currently recruiting, and all genders are welcome to apply.

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 Renal Impairment:
• • Diagnosis of chronic, stable renal function in the 6 months prior to dosing, as determined by the investigator, based on medical history or eGFR, and not requiring dialysis
• Key Exclusion Criteria for All Participants:
• • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).
• Key Exclusion Criteria for Participants with normal Renal function:
• • -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.
• Key Exclusion Criteria for Participants with Renal Impairment:
• • - History of any uncontrolled or unstable hepatic, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.