Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

Inclusion criteria

• Healthy adult female 18 to 50 years of age, inclusive, at the time of consent.
• Weigh at least 50 kg, and have a body mass index within 18 to 35 kg/m2 inclusive.
• Between 10 days and 52 weeks postpartum, inclusive, after delivery of a normal, healthy infant by the time of dosing, and actively lactating from both breasts.
• If breastfeeding, agree to withhold breastfeeding their infant(s) from approximately 2 hours before dosing to approximately 72 hours after dosing and resume breastfeeding after completion of study Day 4 procedures OR have made a decision to wean their infant(s) before enrollment in the study.
• Agree not to use nicotine-containing products including tobacco (cigarettes, cigars, chewing tobacco, snuff), e-cigarettes, and nicotine lozenge/gum/patch within 3 days prior to check-in on Day -1, and for the duration of the study.
• Have used a medically acceptable method of contraception for at least the 2 months prior to dosing on Day 1, and consent to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the study is completed.
• Agree to comply with study-specified diet while in the study.
• Able to understand and comply with study requirements.
• Ensure that their breastfed infant(s) is able to feed from a bottle before study participation begins.
• Agree to ensure nutrition is available for their infant(s) through stored breast milk, or alternative nutritional sources as necessary, for the duration of the study.

Exclusion criteria

• Are pregnant.
• History of any illness, physical finding, laboratory examination or electrocardiogram (ECG) finding that, in the opinion of the investigator, might confound the results or conduct of the study or pose a risk to the participant.
• History or presence of gastrointestinal, hepatic, or renal disease or any other condition that may interfere with absorption, distribution, metabolism, or excretion of drugs.
• Estimated creatinine clearance of < 90 mL/min.
• History of breast implants, breast augmentation, or breast reduction surgery.
• Presence of mastitis or other condition that would prevent the collection of milk from one or both breasts.
• Presence of active suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
• History or presence of any clinically significant cardiovascular conditions.
• Resting supine systolic blood pressure > 140 mmHg or < 90 mmHg or supine diastolic blood pressure > 90 mmHg or < 50 mmHg at the Screening Visit or at predose on Day 1. Blood pressure measurement may be repeated once at the discretion of the investigator.
• Resting supine pulse rate of < 45 beats per minute (bpm) or >100 bpm at the Screening Visit or at predose on Day 1. Pulse rate measurement may be repeated once at the discretion of the investigator.
• Unwilling to refrain from, or anticipates the use of, any medication, including prescription (with the exception of contraceptive agents) and non-prescription drugs (with the exception of acetaminophen no more than 2600 mg a day and ibuprofen no more than 1200 mg a day), antacids, vitamin supplements, or herbal remedies, beginning 14 days or 5 half-lives (whichever is longer) prior to Day 1 through the completion of breast milk collection and blood sampling.
• Use of a monoamine oxidase inhibitor within 14 days prior to Day 1 through the completion of breast milk collection and blood sampling.
• Unwilling to abstain from alcohol or caffeine/xanthine-containing products, including coffee, tea, chocolate, and cola, within 48 hours prior to Day 1 through the completion of breast milk collection and blood sampling.
• Self-reported routine consumption of more than 600 mg of caffeine per day.
• Positive breath alcohol or urine drug screen (including cannabinoids) at screening or at any point throughout the duration of the study.
• Current or past (within the past 2 years) diagnosis of a moderate or severe substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
• Current or history (within the past 2 years) of seeking treatment for a substance related disorder.
• History or presence of phenylketonuria or a hypersensitivity or idiosyncratic reaction to phenylalanine-derived products, or any excipient in the formulated drug product.
• Has participated in another clinical trial of an investigational drug or medical device within 30 days or five half-lives (whichever is longer) prior to Day 1.
• Any other condition that would cause a risk to the participant if they participate in the trial, or to the ability of the participant to complete the study, based on the judgement of the investigator.
• Employee of the study unit or Jazz Pharmaceuticals, anyone involved in the conduct of the trial, and first- and second-degree family member of anyone involved in the conduct of the trial.