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

Alumis

Status and phase: Enrolling; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: ESK-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06952634

ESK-001-022

Details and patient eligibility

About

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.

Full 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.)

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 4 patient groups

Healthy Volunteer

Experimental group

Description:

Up to 24 healthy volunteer participants will receive a single dose of ESK-001

Treatment:

Drug: ESK-001

Mild Hepatic Impairment

Experimental group

Description:

8 participants with mild hepatic impairment will receive a single dose of ESK-001

Treatment:

Drug: ESK-001

Moderate Hepatic Impairment

Experimental group

Description:

8 participants with moderate hepatic impairment will receive a single dose of ESK-001

Treatment:

Drug: ESK-001

Severe Hepatic Impairment

Experimental group

Description:

8 participants with severe hepatic impairment will receive a single dose of ESK-001

Treatment:

Drug: ESK-001