Renal Impairment Study for Oral EC5026

Part of paid clinical trials in Sacramento, California.

Sponsor: EicOsis Human Health Inc.
Study ID: NCT07694544
Phase: PHASE1
Status: Recruiting

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Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: ALL
Age: 55 Years - N/A
Healthy Volunteers: Accepted

Interventions

EC5026 oral tablet — DRUG
Oral 8 mg EC5026 tablet

Study Details

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).

Key Dates

First listed: Jul 10, 2026
Start date: Jul 1, 2026
Status verified: Jul 2026
Primary completion: Dec 31, 2026
Completion: Jun 30, 2027

Study Design

Enrollment: 18 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Control Arm
Participants with normal kidney function receiving a single 8 mg oral dose of EC5026
Experimental: CKD Stage 3b
Participants with CKD Stage 3b receiving a single 8 mg oral dose of EC5026
Experimental: CKD Stage 4/5 (non dialysis)
Participants with CKD Stages 4/5 (non dialysis) receiving a single 8 mg oral dose of EC5026