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

Alumis

Status and phase: Enrolling; Phase 1

Conditions: Renal Impairment

Treatments: Drug: ESK-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06962774

ESK-001-023

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 renal 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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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 Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: ESK-001

Moderate Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: ESK-001

Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: ESK-001