Clinical trial NCT06962774: An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Alumis Inc
Sponsor class: INDUSTRY
First posted: 2025-05-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

Eligibility 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 48 hours
measure: Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
timeFrame: 48 hours
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
timeFrame: 48 hours
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: 48 hours
Secondary outcomes:
measure: Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
timeFrame: 48 hours
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Alumis Inc
name: Jorn Drappa, Medical Director
role: STUDY_DIRECTOR
References: