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
Eisai Inc.
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
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion criteria: 1. 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. 2. Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening. Exclusion criteria: 1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] (or human chorionic gonadotropin \[hCG\]…
Interventions
- DrugE1018
Specified dose on specified days.
- DrugPlacebo
E1018 matching placebo on specified days.
Location
- PPD Development, LPAustin, Texas