NCT06962774

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Alumis Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	ESK-001	Single oral dose of ESK-001 in participants from all cohorts

Timeline

• Start date: 2025-04-23
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2025-05-08
• Last updated: 2025-12-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study