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
Apply to this trial

Conditions

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

Primary Outcome Measure

Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t) [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Jennifer Norman Project Scientist
[email protected]
Baback Roshanravan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
UC Davis Medical Center· Sacramento, CA

Related Studies