An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
NCT ID: NCT06952634
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2025-04-29
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Healthy Volunteer
Up to 24 healthy volunteer participants will receive a single dose of ESK-001
ESK-001
Single oral dose of ESK-001 in participants from all cohorts
Mild Hepatic Impairment
8 participants with mild hepatic impairment will receive a single dose of ESK-001
ESK-001
Single oral dose of ESK-001 in participants from all cohorts
Moderate Hepatic Impairment
8 participants with moderate hepatic impairment will receive a single dose of ESK-001
ESK-001
Single oral dose of ESK-001 in participants from all cohorts
Severe Hepatic Impairment
8 participants with severe hepatic impairment will receive a single dose of ESK-001
ESK-001
Single oral dose of ESK-001 in participants from all cohorts
Interventions
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ESK-001
Single oral dose of ESK-001 in participants from all cohorts
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Alumis Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jorn Drappa, Medical Director
Role: STUDY_DIRECTOR
Alumis Inc
Locations
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Orange County Research Center
Lake Forest, California, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Alliance for Multispecialty Research
Knoxville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ESK-001-022
Identifier Type: -
Identifier Source: org_study_id
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