A Study of Oral E1018 in Healthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEisai Inc.
About this trial
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 criteria
Qualifiers
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/m²) at Screening.
Disqualifiers
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]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of β-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug.
Females of childbearing potential. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method, as described below, throughout the study period and for 28 days after study drug discontinuation. If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 28 days after study drug discontinuation. No sperm donation is allowed during the study period and for 28 days after study drug discontinuation. The duration may be expanded further based on the half-life of the study drug calculated in this study.
total abstinence (if it is their preferred and usual lifestyle)
Trial design
Treatments tested in this trial
- E1018
- Placebo
Treatment groups
32 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov