Actively Recruiting
A First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral E1018 in Healthy Adult Subjects
Led by Eisai Inc. · Updated on 2025-09-24
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) a new oral drug called E1018 in healthy adult volunteers. This early phase 1 study aims to understand how E1018 behaves in the body after a single dose and to monitor any possible side effects. The study includes adults from 18 to 55 years old who do not smoke or vape and have a healthy body mass index. Participants will receive single ascending doses of oral E1018 or a matching placebo in different groups. The study is randomized and double-blinded, meaning neither the participants nor the researchers know who receives the active drug or placebo to ensure unbiased results. Dosages are given on specified days, and the study includes several cohorts to assess the effects of increasing doses. During the study, participants will be closely monitored through physical exams, vital signs, laboratory tests, electrocardiograms (ECGs), and urine and blood sample collections to measure drug levels and safety markers. The primary outcomes include tracking any adverse events, dose-limiting toxicities, and detailed pharmacokinetic measurements up to 20 days after dosing. Participation involves regular visits for assessments and lasts through the observation period to ensure safety and gather data.
CONDITIONS
Brief Title
A Study of Oral E1018 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female nonsmokers aged 18 to 55 years at the time of consent
- Discontinued smoking/vaping for at least 4 weeks before dosing
- Body Mass Index (BMI) of 18 to less than 30 kg/m² at screening
You will not qualify if you...
- Females who are pregnant or breastfeeding at screening or baseline
- Females of childbearing potential unless postmenopausal or surgically sterilized
- Males without successful vasectomy if partner is of childbearing potential and not using effective contraception
- Clinically significant illness requiring treatment within 8 weeks or infection within 4 weeks before dosing
- Concurrent febrile illness at screening or baseline
- History of surgery affecting drug metabolism or congenital metabolic abnormalities
- Clinically abnormal symptoms or organ impairment needing treatment at screening or baseline
- Left bundle branch block
- History of myocardial infarction, active ischemic heart disease, or significant arrhythmia
- Known history of significant drug allergy
- Known food allergies or significant seasonal/perennial allergies at screening
- HIV positive status at screening
- Active viral hepatitis A, B, or C at screening
- History of drug or alcohol dependency or positive drug/alcohol tests at screening or baseline
- Enrollment in another clinical study or use of investigational drug/device within 30 days or 5 half-lives prior to consent
- Receipt of blood products within 4 weeks, or blood/plasma donation within specified timeframes before dosing
- History of noncompliance or inability to comply with study conduct
- Any other findings increasing risk of adverse outcomes from study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 days
Participants receive a single ascending dose of oral E1018 or matching placebo to assess safety, tolerability, and pharmacokinetics.
Several visits until Day 20 for assessments
Trial Site Locations
Total: 1 location
1
PPD Development, LP
Austin, Texas, United States, 78744
Actively Recruiting
Research Team
E
Eisai Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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