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An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT06952634•Alumis Inc

View on ClinicalTrials.gov

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.

Detailed Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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.

Locations (4)

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

Key Dates

Start Date

April 29, 2025

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

May 1, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatic Impairment

Interventions

ESK-001

DRUG

Contacts

Central Contact

CONTACT

(650) 231-6625 nharada@alumis.com

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

NCT07324616

Hepatic Impairment (HI)

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RECRUITINGPHASE1

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

NCT04271488

Hepatic Impairment

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COMPLETEDPHASE1

A Varegacestat Hepatic Impairment Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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