Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01673451
Eligibility Criteria:
Included:
* Healthy males or females, ages 18 to 55 years (Part A) or 65 to 80 years (Part B)
* Who report typical time in bed 7.5 to 9 hours
* Who report typical bedtime 22:00 - 24:00 and typical wake time 06:00 - 08:00
* Who report typical sleep latency of \<= 30 minutes
* All females must be of non-childbearing potential, or subjects who have been sterilized surgically or who are otherwise proven sterile. Females must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) test result at Screening and a negative urine pregnancy test at Baseline.
* Body mass index BMI \> 18 and 32 kg/m2 at Screening
Excluded:
* Performed shift work within 2 weeks prior to Screening
* Had taken a flight across three or more time zones in the 7 days prior to Screening
* Female subjects who are nursing
* With a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profile of E2006
* With a known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
* Hypersensitivity to the study drug or any of the excipients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01673451
Study Brief:
Protocol Section:
NCT01673451