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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT02852395
Eligibility Criteria:
Inclusion Criteria:
* Must be healthy as assessed by medical history and safety evaluations performed at screening
* Has a body mass index between 18 and 30 kilogram per square meter (kg/m2) and body weight not less than 50 kg
* Must be willing and able to abide by the prohibitions and restrictions of the study, including requirements for contraception
* Women must not be of childbearing potential by either being postmenapausal or permanently sterilized
* Part 2 Only: Maintains a regular sleep-wake cycle as measured by sleep diaries and a watch that measures activity
* Has a habitual (majority of days) bedtime and duration of sleep that meet the study requirements
Exclusion Criteria:
* Current or history of clinically significant medical or psychiatric illness, or recent major surgery or blood loss/donation
* Any current sleep-wake disorder, recent night shift work, or history of insomnia within the last 5 years
* Man who has a pregnant female partner
* Woman who is breastfeeding
* Is participating or has participated within the last 3 months in a study with an investigational drug or medical device
* Tests positive or has a history of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other active liver disease
* Drug or alcohol abuse within the last 5 years, nicotine use within the last 3 months, or tests positive for alcohol, drugs of abuse, or nicotine
* Routinely consumes an excessive amount of caffeine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02852395
Study Brief:
Protocol Section:
NCT02852395