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

NCT ID: NCT06962774

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-23
• Study Completion Date: 2025-08-01

Brief 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 renal 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.)

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mild Renal Impairment

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

Group Type: EXPERIMENTAL

ESK-001

Intervention Type: DRUG

Single oral dose of ESK-001 in participants from all cohorts

Moderate Renal Impairment

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

Group Type: EXPERIMENTAL

ESK-001

Intervention Type: DRUG

Single oral dose of ESK-001 in participants from all cohorts

Severe Renal Impairment

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

Group Type: EXPERIMENTAL

ESK-001

Intervention Type: DRUG

Single oral dose of ESK-001 in participants from all cohorts

Healthy Volunteer

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

Group Type: EXPERIMENTAL

ESK-001

Intervention Type: DRUG

Single oral dose of ESK-001 in participants from all cohorts

Interventions

ESK-001

Single oral dose of ESK-001 in participants from all cohorts

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index between 18.0 and 40.0 kg/m2

• 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

Exclusion Criteria

• 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).

-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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alumis Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorn Drappa, Medical Director

Role: STUDY_DIRECTOR

Alumis Inc

Locations

Advanced Pharma CR

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Other Identifiers

ESK-001-023

Identifier Type: -

Identifier Source: org_study_id