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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT06219902
Eligibility Criteria:
Inclusion Criteria:
* Females aged 40 to 65 years, inclusive, at signing of informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and electrocardiogram (ECG).
* Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
* Participant possesses a valid driver's license and is an active driver. Drives a minimum of 8,000 kilometers per year for the previous 3 years.
Exclusion Criteria:
* Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
* A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
* Abnormal finding in the physical examination, ECG, blood pressure, pulse rate or clinical laboratory results at Screening, that are considered clinically significant by the investigator.
* Use of any medication of dietary supplement which may affect central nervous system (CNS) function and may confound the pharmacodynamic assessments of the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06219902
Study Brief:
Protocol Section:
NCT06219902