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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT06348303
Eligibility Criteria:
Inclusion Criteria:
* Weigh at least 120 pounds at Screening
* Medically healthy with no clinically significant medical co-morbidities impact endpoints
Exclusion Criteria:
* Current use of any medications known to affect sleep-wake cycle.
* Known sleep disorder.
* Current use of cimetidine.
* Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
* Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
* Participants taking skeletal muscle relaxants or sedative hypnotics.
* Participants with gastrointestinal disease affecting absorption.
* Participants with severe hepatic or renal impairment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06348303
Study Brief:
Protocol Section:
NCT06348303