A Study of Oral E1018 in Healthy Adult Participants

Part of paid clinical trials in Austin, Texas.

Sponsor
Eisai Inc.
Study ID
NCT06854042
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants
  • Malaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • E1018 — DRUG
    Specified dose on specified days.
  • Placebo — DRUG
    E1018 matching placebo on specified days.

Study Details

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.

Key Dates

Start date
Feb 26, 2025
Status verified
Sep 2025
Primary completion
Dec 23, 2025
Completion
Dec 23, 2025

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: E1018 or Placebo
  • Experimental: Cohort 2: E1018 or Placebo
  • Experimental: Cohort 3: E1018 or Placebo
  • Experimental: Cohort 4: E1018 or Placebo

Primary Outcome Measure

Number of Participants With Dose-limiting Events [ Time Frame: Up to Day 20 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PPD Development, LPAustinTexas78744-

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By research site
PPD Development, LP· Austin, TX

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