An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function
- Registration Number
- NCT06962774
- Lead Sponsor
- Alumis Inc
- 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.)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Volunteer ESK-001 Up to 24 healthy volunteer participants will receive a single dose of ESK-001 Mild Renal Impairment ESK-001 8 participants with mild renal impairment will receive a single dose of ESK-001 Moderate Renal Impairment ESK-001 8 participants with moderate renal impairment will receive a single dose of ESK-001 Severe Renal Impairment ESK-001 8 participants with severe Renal impairment will receive a single dose of ESK-001
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) 48 hours Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation 48 hours Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] 48 hours Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] 48 hours
- Secondary Outcome Measures
Name Time Method Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations 48 hours
Trial Locations
- Locations (4)
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Advanced Pharma CR
🇺🇸Miami, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States