Renal Impairment Study for Oral EC5026
This study is testing a single 8 mg dose of an oral tablet called EC5026. Researchers want to understand how the body processes EC5026 in people aged 55 and older who have chronic kidney disease (CKD), specifically stages 3b-5. They will compare this to how healthy people with normal kidney function process the drug. The main goals are to see if the drug's levels in the body are different in people with CKD and to check if EC5026 is safe and well-tolerated. The study plans to enroll 18 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 18 participants aged 55 and older.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for the drug's levels in the body will be taken at 14 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Renal Impairment Study for Oral EC5026
At a glance
Conditions
NCT07694544
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
UC Davis Medical Center
Sacramento, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.