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

ClinicalTrials.gov ID: NCT06962774

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Official title

A Phase 1, Open-label, Single-dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of a Single Oral Dose of ESK-001

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06962774
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Alumis Inc; Industry
Enrollment: 16 participants

Conditions and interventions

Conditions

Renal Impairment

Interventions

ESK-001 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 23, 2025 (Actual)
Primary completion: Aug 1, 2025 (Actual)
Completion: Aug 1, 2025 (Actual)
Last update posted: Dec 10, 2025

2025

United States locations

U.S. sites: 4
U.S. states: 1
U.S. cities: 3

Facility	City	State	ZIP	Site status
Advanced Pharma CR	Miami	Florida	33147	—
Panax Clinical Research	Miami Lakes	Florida	33014	—
Floridian Clinical Research	Miami Lakes	Florida	33016	—
Orlando Clinical Research Center	Orlando	Florida	32809	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06962774, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 10, 2025 · Synced Nov 14, 2026