The Role of the LC-NA System in Experimental Sleep Fragmentation

Exclusion Criteria18

• Present use of medication that may interfere with sleep or study drugs
• Travel across 3 or more time zones within 3 months of study start
• Habitual napping
• Extreme chronotype, determined by reduced Morningness-Eveningness Questionnaire (rMEQ) score: 8 < rMEQ > 21)
• Shift working within 2 weeks prior to the screening visit
• History of or presence of a trauma- or stressor-related disorder
• Serious acute or chronic neurological, mental, or general medical conditions that, in the opinion of the investigator, may pose a risk to participation or affect study measurements
• History of or presence of a sleep wake disorder
• Use of illicit drugs (positive urinary drug screening)
• Male participants who are not vasectomised for at least 6 months prior to dosing and who are sexually active with a female partner of childbearing potential not willing to use one of the following acceptable contraceptive methods from the first dose and for 3 months after the last dose:
• Use of condom and/or hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
• Male participants (including men who have had a vasectomy) with a pregnant partner not willing to use a condom from the first dose and for 3 months after the last dose.
• Male participants not willing to abstain from sperm donation for 3 months after the last dose
• Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) not willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration:
• Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
• \- Females of non-childbearing potential who are neither: Post-menopausal (status defined as an absence of menses for at least 12 months prior to the first study drug administration); or Surgically sterilized (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration)
• Faints at the sight of blood (applies only for the pharmacokinetic-part of the study)
• Has participated in a study < 30 days or a study such as this (i.e., experimental trauma) at all.