A Study of Oral E1018 in Healthy Adult Participants
← catalyst calendarNCT06854042 · readout in 337 d
Sponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
32estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-26 | actual | When the study began enrolling |
| Primary completion | 2027-07-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-07-22 | estimated | The whole study's end, after follow-up |
| First posted | 2025-03-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Malaria
- Healthy Participants
Interventions
- Drug: E1018
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Dose-limiting Events
measured Up to Day 20
Number of Participants With Adverse Events (Serious and Non-serious)
measured Up to Day 20
Number of Participants With Clinically Significant Laboratory Test Results
measured Up to Day 20
Number of Participants With Clinically Significant Vital Signs Values
measured Up to Day 20
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
measured Up to Day 20
AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E1018
measured Up to Day 20
AUC(0-inf): Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E1018
measured Up to Day 20
Cmax: Maximum Observed Concentration for E1018
measured Up to Day 20
Tmax: Time at Which the Highest Drug Concentration Occurs for E1018
measured Up to Day 20
t½: Terminal Elimination Phase Half-life for E1018
measured Up to Day 20
CL/F: Apparent Total Clearance Following Oral Administration for E1018
measured Up to Day 20
Vz/F: Apparent Volume of Distribution at Terminal Phase for E1018
measured Up to Day 20
Ae: Cumulative Amount of E1018 Excreted in the Urine
measured Up to Day 6
Fe: Percent (%) of Administered E1018 Dose Excreted in Urine
measured Up to Day 6
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