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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
EC5026 oral tablet
DrugOral 8 mg EC5026 tablet
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Control ArmExperimental treatment 1 intervention
Group B: CKD Stage 3bExperimental treatment 1 intervention
Group C: CKD Stage 4/5 (non dialysis)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
14 days2
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.
Time frame
14 days3
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.
Time frame
14 days4
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.
Time frame
14 daysSecondary outcomes
1
Incidence, intensity, relationship, and seriousness of treatment-emergent adverse events (TEAEs)
Treatment-emergent adverse events are adverse events that begin or worsen after administration of study drug. Adverse events will be assessed throughout the study and summarized by incidence, intensity (severity), relationship to study drug as determined by the investigator, and seriousness. Adverse events will be coded using the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame
14 days2
Treatment-emergent changes in vital signs
Vital signs, including systolic and diastolic blood pressure, heart rate, respiratory rate, body temperature, and body weight, will be measured at prespecified study visits. Treatment-emergent changes from baseline and clinically significant abnormalities will be summarized.
Time frame
14 days3
Treatment-emergent changes in hematology laboratory parameters
Hematology laboratory assessments, including complete blood count and differential, will be performed at prespecified study visits. Treatment-emergent changes from baseline and clinically significant laboratory abnormalities will be summarized.
Time frame
14 days4
Treatment-emergent changes in serum chemistry laboratory parameters
Serum chemistry laboratory assessments, including electrolytes, liver function tests, glucose, and other serum chemistry analytes, will be performed at prespecified study visits. Treatment-emergent changes from baseline and clinically significant laboratory abnormalities will be summarized.
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov