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NCT07694544 · ClinicalTrials.gov registry record · Phase 1
Renal Impairment Study for Oral EC5026
A Phase 1 study, sponsored by EicOsis Human Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07694544: Recruiting Phase 1 study, sponsored by EicOsis Human Health.
NCT07694544 is a Phase 1 study that is actively recruiting participants, run by EicOsis Human Health. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07694544, a Phase 1 study, is actively recruiting participants, sponsored by EicOsis Human Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
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).
Primary Outcome
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.
Interventions
- DRUG EC5026 oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
What NCT07694544 shows while recruiting
NCT07694544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which EC5026 oral tablet is the first listed.
NCT07694544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07694544 about?
NCT07694544 is a clinical study titled "Renal Impairment Study for Oral EC5026". 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 ...
What is the current status of trial NCT07694544?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-07-01. Estimated completion is 2027-06-30.
What interventions are being tested in trial NCT07694544?
The interventions under investigation include: EC5026 oral tablet (DRUG).
Who is sponsoring clinical trial NCT07694544?
This trial is sponsored by EicOsis Human Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07694544's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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