Renal Impairment Study for Oral EC5026
Condition(s) studied
Investigational drug(s) / intervention(s)
EC5026 oral tablet: Oral 8 mg EC5026 tablet
Study 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
Primary outcome measure(s)
- Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t) — 14 days
The area under the plasma concentration-time curve from dosing until the last measurable concentration. Plasma concentrations will be measured from blood samples collected at prespecified time points (0, 2, 4, 6, 8, 24 hours, and 3, 5, 7, 14 days after administration) using a validated bioanalytical assay. AUC0-t will be calculated using noncompartmental pharmacokinetic methods and represents systemic exposure to the study drug over the measured sampling interval. - Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) — 14 days
The area under the plasma concentration-time curve from dosing extrapolated to infinite time. Plasma concentrations will be measured from blood samples collected at prespecified time points (see above) using a validated bioanalytical assay. AUC0-∞ will be calculated using noncompartmental pharmacokinetic methods and represents the total systemic exposure to the study drug. - Maximum observed plasma concentration (Cmax) — 14 days
The highest observed plasma concentration of the study drug following administration. Plasma concentrations will be measured from blood samples collected at prespecified time points (see above) using a validated bioanalytical assay. - Time to the maximum observed concentration of the drug (Tmax) — 14 days
The time from study drug administration to the maximum observed plasma concentration (Cmax). Tmax will be determined directly from the observed plasma concentration-time data. - Apparent terminal elimination rate constant (Kel) — 14 days
The apparent rate at which the study drug is eliminated from plasma during the terminal phase after administration. Kel will be estimated from the terminal log-linear portion of the plasma concentration-time curve using noncompartmental pharmacokinetic methods. - Terminal elimination half-life of the drug (t½). — 14 days
The time required for the plasma concentration of the study drug to decrease by 50% during the terminal elimination phase. Half-life will be estimated from the terminal elimination rate constant using noncompartmental pharmacokinetic methods. - Apparent clearance (CL/F). — 14 days
The apparent volume of plasma from which the study drug is removed per unit time following oral administration, accounting for unknown oral bioavailability (F). Apparent clearance will be estimated using noncompartmental pharmacokinetic methods. - Apparent volume of distribution during the terminal phase (Vz/F) — 14 days
The apparent volume into which the study drug distributes during the terminal elimination phase following oral administration, accounting for unknown oral bioavailability (F). This parameter will be estimated using noncompartmental pharmacokinetic methods. - Renal clearance (CLR) — 48 hours
The apparent volume of plasma from which unchanged study drug is removed by the kidneys per unit time. Renal clearance will be calculated using plasma concentration and urine excretion data collected over prespecified sampling intervals. - Amount of unchanged drug excreted in urine (Ae). — 48 hours
The cumulative amount of unchanged study drug recovered in urine following study drug administration. Urine samples will be collected over prespecified time intervals and analyzed using a validated bioanalytical assay. - Fraction of eliminated dose (Fe%) — 48 hours
The percentage of the administered study drug dose recovered unchanged in urine over the specified collection period. Fe% will be calculated from the cumulative amount of unchanged drug excreted in urine relative to the administered dose.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07694544 on ClinicalTrials.gov ↗ ← All trials in the USA