Assessment of Single Dose Pharmacokinetics of Oral EC5026 in a Population With Chronic Kidney Disease
EicOsis Human Health Inc.
Summary
The goal of this Phase 1 clinical trial is to assess single dose pharmacokinetics of oral EC5026 in a population with chronic kidney disease. The main questions it aims to answer are: 1. To determine if the PK of a single 8 mg dose of EC5026, administered orally, in adult participants with varying severity of CKD differs from age-matched healthy participants with normal kidney function. 2. To determine if a single 8 mg dose of EC5026, administered orally, in adult participants with varying severity of CKD is safe and well tolerated. Researchers will compare a single 8 mg dose of oral across participants with varying degrees of kidney function impairment (either normal kidney function, or stage 3b chronic kidney disease \[CKD\], or state 4/5 CKD). Participants will be asked to take a single oral dose of EC5026 and will be monitored with PK laboratory assessments and safety assessments (including physical exams, vital signs, electrocardiograms, and others).
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Each study participant must meet all of the following criteria to be enrolled in this study: 1. Male and female participants must be 55 and older. 2. Study participants must be willing and able to provide written informed consent to participate in the study. 3. Participants with CKD must be stage 3b-5 (estimated glomerular filtration rate (eGFR) ≤ 44 ml/min per 1.73m2) without dialysis. Control participants must have an eGFR of ≥90 ml/min per 1.73m2. 4. Aside from the diagnosis of CKD, study participants must be in overall stable condition, as determined by pre-study medi…
Interventions
- DrugEC5026 oral tablet
Oral 8 mg EC5026 tablet
Location
- UC Davis Medical CenterSacramento, California