A Study of Oral E1018 in Healthy Adults
This study is testing a new oral drug called E1018 in healthy adults. The main goals are to see how safe E1018 is, how well your body tolerates it, and how it moves through your body (pharmacokinetics). You might receive E1018 or a placebo (an inactive substance that looks like the drug). We're looking for about 32 healthy adults between 18 and 55 years old who don't smoke or vape and have a BMI between 18 and 30. We'll measure safety by tracking any side effects or unusual lab results for up to 20 days. The current status of this study is unclear.
- Study design
- This is an interventional study involving about 32 healthy adult participants. It compares E1018 to a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for safety and side effects for up to 20 days after receiving the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06854042
A Study of Oral E1018 in Healthy Adult Participants
Active, Not Recruiting
PHASE1Ages 18–55InterventionalTreatmentEisai Inc.
~32 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:E1018Placebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Dose-limiting Events
Measured over Up to Day 20
+13 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
total abstinence (if it is their preferred and usual lifestyle)
an intrauterine device or intrauterine hormone-releasing system
a contraceptive implant
an oral contraceptive (the participant's partner must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of oral contraceptive throughout the study and for 28 days after study drug discontinuation). It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant's partner, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. The duration of contraception period may be extended based on the half-life of the study drug calculated in this study. 4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing. 5. Presence of concurrent febrile illness(es) at Screening or Baseline. 6. 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. 7. 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. 8. Left bundle branch block. 9. History of myocardial infarction, active ischemic heart disease, or clinically significant or uncontrolled arrhythmia. 10. Known history of clinically significant drug allergy at Screening. 11. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening. 12. Known to be human immunodeficiency virus (HIV)-positive at Screening. 13. Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening. 14. History of drug or alcohol dependency or abuse, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline. 15. Currently enrolled in another clinical study or used any investigational drug or device within 30 days or 5 half-lives (whichever is longer) preceding informed consent. 16. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing. 17. A history of noncompliance in any previous study or inability to comply with study conduct, as assessed by the investigator. 18. Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the study.
What this trial measures
- Number of Participants With Dose-limiting EventsUp to Day 20
- Number of Participants With Adverse Events (Serious and Non-serious)Up to Day 20
- Number of Participants With Clinically Significant Laboratory Test ResultsUp to Day 20
- Number of Participants With Clinically Significant Vital Signs ValuesUp to Day 20
- Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) ResultsUp to Day 20
- AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E1018Up to Day 20
- AUC(0-inf): Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E1018Up to Day 20
- Cmax: Maximum Observed Concentration for E1018Up to Day 20
- Tmax: Time at Which the Highest Drug Concentration Occurs for E1018Up to Day 20
- t½: Terminal Elimination Phase Half-life for E1018Up to Day 20
- CL/F: Apparent Total Clearance Following Oral Administration for E1018Up to Day 20
- Vz/F: Apparent Volume of Distribution at Terminal Phase for E1018Up to Day 20
- Ae: Cumulative Amount of E1018 Excreted in the UrineUp to Day 6
- Fe: Percent (%) of Administered E1018 Dose Excreted in UrineUp to Day 6