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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Nonsmoking/vaping, male or female, age greater than or equal to (\>=) 18 years to less than or equal (\<=) 55 years old at the time of informed consent. To be considered nonsmokers, participant must have discontinued smoking/vaping for at least 4 weeks before dosing.
• Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening.
Locations
United States
Texas
PPD Development, LP
RECRUITING
Austin
Contact Information
Primary
Eisai Medical Information
esi_medinfo@eisai.com
+1-888-274-2378
Time Frame
Start Date: 2025-02-26
Estimated Completion Date: 2025-12-23
Participants
Target number of participants: 32
Treatments
Experimental: Cohort 1: E1018 or Placebo
Experimental: Cohort 2: E1018 or Placebo
Experimental: Cohort 3: E1018 or Placebo
Experimental: Cohort 4: E1018 or Placebo
Related Therapeutic Areas
Sponsors
Leads: Eisai Inc.