Investigating ESK-001 in patients with varying levels of 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
This study is testing how well the drug ESK-001 works in people with different levels of kidney function to see if it affects how the body absorbs and processes the medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Alumis Inc Industry-sponsored |
| Locations | 4 sites (Miami Lakes, Florida and 3 other locations) |
| Trial ID | NCT06962774 on ClinicalTrials.gov |
What this trial studies
This phase 1, open-label, single-dose, parallel cohort study aims to evaluate the pharmacokinetics of ESK-001 in healthy volunteers and participants with mild, moderate, and severe renal impairment. The study will include individuals with chronic, stable renal function who are not on dialysis, allowing researchers to understand how renal function affects the drug's absorption and metabolism. Participants will be monitored for safety and efficacy as part of the trial's methodology.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic renal impairment who are not on dialysis and have a stable medical history.
Not a fit: Patients with significant metabolic or systemic disorders that could affect drug absorption or metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing guidelines for ESK-001 in patients with renal impairment.
How similar studies have performed: Other studies investigating pharmacokinetics in renal impairment have shown promise, suggesting that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami Lakes, Florida and 3 other locations
- Panax Clinical Research — Miami Lakes, Florida, United States (Recruiting)
- Floridian Clinical Research — Miami Lakes, Florida, United States (Recruiting)
- Advanced Pharma CR — Miami, Florida, United States (Recruiting)
- Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Central Contact
- Email: nharada@alumis.com
- Phone: (650) 231-6625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.