Status:
COMPLETED
An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function
Lead Sponsor:
Alumis Inc
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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, a...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06962774
Start Date
April 23 2025
End Date
August 1 2025
Last Update
December 10 2025
Active Locations (4)
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1
Advanced Pharma CR
Miami, Florida, United States, 33147
2
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
3
Floridian Clinical Research
Miami Lakes, Florida, United States, 33016
4
Orlando Clinical Research Center
Orlando, Florida, United States, 32809