A Study of Oral E1018 in Healthy Adult Participants (NCT06854042) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Oral E1018 in Healthy Adult Participants
United States32 participantsStarted 2025-02-26
Plain-language summary
The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to evaluate the pharmacokinetics (PK) of E1018 in plasma and urine after single oral dose administration.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Nonsmoking/vaping, male or female, age greater than or equal to (\>=) 18 years to less than or equal (\<=) 55 years old at the time of informed consent. To be considered nonsmokers, participant must have discontinued smoking/vaping for at least 4 weeks before dosing.
. Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening.
Exclusion criteria
. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] (or human chorionic gonadotropin \[hCG\]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of β-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug.
. Females of childbearing potential. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method, as described below, throughout the study period and for 28 days after study drug discontinuation. If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 28 days after study drug discontinuation. No sperm donation is allowed during the study period and for 28 days after study drug discontinuation. The duration may be expanded further based on the half-life of the study drug calculated in this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Dose-limiting Events
Timeframe: Up to Day 20
2
Number of Participants With Adverse Events (Serious and Non-serious)
Timeframe: Up to Day 20
3
Number of Participants With Clinically Significant Laboratory Test Results
Timeframe: Up to Day 20
4
Number of Participants With Clinically Significant Vital Signs Values
Timeframe: Up to Day 20
5
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Timeframe: Up to Day 20
6
AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E1018
Timeframe: Up to Day 20
7
AUC(0-inf): Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E1018
. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
. Presence of concurrent febrile illness(es) at Screening or Baseline.
. Any history of surgery that may affect PK profiles of E1018 (example, hepatectomy, nephrectomy, digestive organ resection) or participants who have a congenital abnormality in metabolism at Screening.
. Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline.
. Left bundle branch block.
8
Cmax: Maximum Observed Concentration for E1018
Timeframe: Up to Day 20
9
Tmax: Time at Which the Highest Drug Concentration Occurs for E1018
Timeframe: Up to Day 20
10
t½: Terminal Elimination Phase Half-life for E1018
Timeframe: Up to Day 20
11
CL/F: Apparent Total Clearance Following Oral Administration for E1018
Timeframe: Up to Day 20
12
Vz/F: Apparent Volume of Distribution at Terminal Phase for E1018
Timeframe: Up to Day 20
13
Ae: Cumulative Amount of E1018 Excreted in the Urine
Timeframe: Up to Day 6
14
Fe: Percent (%) of Administered E1018 Dose Excreted in Urine