Renal Impairment Study for Oral EC5026
ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age55+
SponsorEicOsis Human Health Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Participants who have donated and/or received any blood or blood products (more than 450 mL) within 3 months prior to enrollment.
Trial design
Treatments tested in this trial
- EC5026 oral tablet
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov