A Study of Oral E1018 in Healthy Adult Participants

Phase 1

Recruiting

• Conditions: Malaria; Healthy Participants
• Interventions: Drug: E1018; Drug: Placebo

• Registration Number: NCT06854042
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study Start: 2025-02-26
• Study First Posted: 2025-03-03
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-18
• Primary Completion: 2025-12-23
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: E1018 or Placebo	E1018	-
Cohort 1: E1018 or Placebo	Placebo	-
Cohort 2: E1018 or Placebo	E1018	-
Cohort 2: E1018 or Placebo	Placebo	-
Cohort 3: E1018 or Placebo	E1018	-
Cohort 3: E1018 or Placebo	Placebo	-
Cohort 4: E1018 or Placebo	E1018	-
Cohort 4: E1018 or Placebo	Placebo	-
Cohort 5: E1018 or Placebo	E1018	-
Cohort 5: E1018 or Placebo	Placebo	-
Cohort 6: E1018 or Placebo	E1018	-
Cohort 6: E1018 or Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose-limiting Toxicities	Up to Day 20
t½: Terminal Elimination Phase Half-life for E1018	Up to Day 20
CL/F: Apparent Total Clearance Following Oral Administration for E1018	Up to Day 20
Fe: Percent (%) of Administered E1018 Dose Excreted in Urine	Up to Day 6
Ae: Cumulative Amount of E1018 Excreted in the Urine	Up to Day 6
Number of Participants With Adverse Events (Serious and Non-serious)	Up to Day 20
Number of Participants With Clinically Significant Laboratory Test Results	Up to Day 20
Number of Participants With Clinically Significant Vital Signs Values	Up to Day 20
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results	Up to Day 20
AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E1018	Up to Day 20
AUC(0-inf): Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E1018	Up to Day 20
Cmax: Maximum Observed Concentration for E1018	Up to Day 20
Tmax: Time at Which the Highest Drug Concentration Occurs for E1018	Up to Day 20
Vz/F: Apparent Volume of Distribution at Terminal Phase for E1018	Up to Day 20

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States