Renal Impairment Study for Oral EC5026

NCT07694544 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EC5026-1-06
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Chronic Kidney Disease

Keywords

Renal impairment study; EC5026; sEH inhibitor; Chronic kidney disease (CKD)

Outcome Measures

Primary Outcomes (11)

• Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)

  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.

  14 days

• Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)

  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.

  14 days

• Maximum observed plasma concentration (Cmax)

  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.

  14 days

• Time to the maximum observed concentration of the drug (Tmax)

  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.

  14 days

• Apparent terminal elimination rate constant (Kel)

  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.

  14 days

• Terminal elimination half-life of the drug (t½).

  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.

  14 days

• Apparent clearance (CL/F).

  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.

  14 days

• Apparent volume of distribution during the terminal phase (Vz/F)

  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.

  14 days

• Renal clearance (CLR)

  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.

  48 hours

• Amount of unchanged drug excreted in urine (Ae).

  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.

  48 hours

• Fraction of eliminated dose (Fe%)

  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.

  48 hours

Secondary Outcomes (7)

• Incidence, intensity, relationship, and seriousness of treatment-emergent adverse events (TEAEs)

  14 days

• Treatment-emergent changes in vital signs

  14 days

• Treatment-emergent changes in hematology laboratory parameters

  14 days

• Treatment-emergent changes in serum chemistry laboratory parameters

  14 days

• Treatment-emergent changes in renal function assessments

  14 days

Study Arms (3)

Control Arm

EXPERIMENTAL

Participants with normal kidney function receiving a single 8 mg oral dose of EC5026

Drug: EC5026 oral tablet

CKD Stage 3b

EXPERIMENTAL

Participants with CKD Stage 3b receiving a single 8 mg oral dose of EC5026

Drug: EC5026 oral tablet

CKD Stage 4/5 (non dialysis)

EXPERIMENTAL

Participants with CKD Stages 4/5 (non dialysis) receiving a single 8 mg oral dose of EC5026

Drug: EC5026 oral tablet

Interventions

EC5026 oral tablet DRUG

Oral 8 mg EC5026 tablet

CKD Stage 3b; CKD Stage 4/5 (non dialysis); Control Arm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each study participant must meet all of the following criteria to be enrolled in this study:
• Male and female participants must be 55 and older.
• Study participants must be willing and able to provide written informed consent to participate in the study.
• Participants with CKD must be stage 3b-5 (estimated glomerular filtration rate (eGFR) ≤ 44 ml/min per 1.73m2) without dialysis. Control participants must have an eGFR of ≥90 ml/min per 1.73m2.
• Aside from the diagnosis of CKD, study participants must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead ECG measurements.
• Study participants must have a body mass index (BMI) of 19-40 kg/m2. Participants with a BMI below 19 kg/m2 may be enrolled at the Investigator's discretion.
• Study participants must have a systolic blood pressure (BP) of 90-170 mmHg, diastolic BP of 50-90 mmHg, and resting HR of 40-100 beats per min at Screening, with or without stable doses of anti-hypertensive medication.
• Study participants must be non-smokers or previous smokers who have not smoked within the previous 6 months prior to Screening.

You may not qualify if:

• Male participants must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
• Male participants must use, from enrollment until at least 2 months after the last dose, a highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), e.g.: sterilization (e.g., vasectomy), and/or double barrier forms of contraception, including condoms (external or internal) and diaphragm ('cap').
• Female participants must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or they must agree to use a highly effective double barrier contraception method (less than 1 pregnancy per 100 people using the method for one year), from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after the end of study. Postmenopausal status will be defined as follows: documented postmenopausal status as determined by a physician in medical record at least 1 year prior or amenorrhea duration of 12 consecutive months and a serum FSH value \>40 IU/L (postmenopausal status must be confirmed at Screening). Highly effective double barrier contraception methods include: Intra-uterine device containing either copper or levonorgestrel (e.g., Mirena®), and/or barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Participants/Participant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative prior to dosing.
• Study participants meeting any of the following criteria will be excluded from the study:
• Participants who have donated and/or received any blood or blood products (more than 450 mL) within 3 months prior to enrollment.
• Participants who have used any other investigational drug within 1 month prior to Screening. If the investigational drug is known to have a long half-life, a longer washout period will be done.
• Participants using opioid medications on a regular basis or pro re nata (PRN). Non-opioid pain medications will be allowed if at a fixed stable dose for more than 1 month prior to Screening with no anticipation of the dose changing during the study. Allowed non-opioid medications include gabapentin, pregabalin, duloxetine, acetaminophen, ibuprofen, celecoxib, meloxicam, other antidepressants including amitriptyline, and other antiepileptics, as well as topical capsaicin and topical lidocaine.
• Participants who have used (within 30 days of enrollment) or plan on using during the duration of the study any prescription or over-the-counter drugs that are cytochrome P450 3A4 (CYP3A4) inducers or inhibitors (e.g., verapamil, diltiazem, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole, itraconazole, fluconazole, erythromycin, or clarithromycin).
• Participants who have used (within 30 days of enrollment) or plan on using during the duration of the study any dietary aids, supplements, or foods that are known to modulate drug metabolizing enzymes (e.g., St. John's wort, grapefruit juice).
• Participants with difficulty in swallowing oral medications.
• Participants who have active cancer or have a high risk of cancer recurrence requiring active surveillance. Participants with a personal history of cancer or metastatic cancer in first degree relatives suggestive of elevated cancer risk in the opinion of the investigator.
• Participants with a history of disorders of the hypothalamic-pituitary-adrenal or hypothalamic-pituitary-gonadal axis
• Participants with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or hepatic, or coagulant disorder within 1 month prior to enrollment
• Participants with any clinically unstable cardiovascular (including acute coronary syndrome within the 6 months prior to Screening), respiratory, hematological, endocrine disorder, as determined by the study physician.
• Participants with severe systolic heart failure (Ejection Fraction \<35%).

Sponsors & Collaborators

• EicOsis Human Health Inc.: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

EC5026

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

EicOsis Senior Clinical Scientist

CONTACT

301-821-5857; icortespuch@eicosis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)