Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp

Exclusion Criteria

• •Is pregnant or unwilling or unable to comply with the lifestyle guidelines presented in the protocol during the study period and through the Post-Study visit
• •Has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including post-natal depression), neurologic, allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing), or a history of neoplastic disease or any active cancer
• •Is mentally or legally incapacitated
• •Has a history of any illness or clinical findings that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant or infant by participation in the study
• •Anticipates the use of prescription or non-prescription drugs that are strong CYP3A4 inducers, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days of study drug administration (or 14 days if the drug is a potential enzyme inducer)
• •Is unable to refrain from consumption of grapefruit juice, grapefruits, grapefruit products, star fruit, Seville and blood oranges, apple and mulberry juice as well as vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard), charbroiled meats, and fenugreek beginning approximately 7 days prior to administration of the initial dose of study drug and throughout the participant's stay in the clinic
• •Consumes significant amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 mL/10 ounces\], wine \[125 mL/4 ounces\] or distilled spirits \[25 mL/1 ounce\]) per day. Participant is unable to refrain from all alcohol consumption within one week prior to study dosing throughout the study until the final study visit
• •Consumes excessive amounts of caffeine for one month prior to study drug administration, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other caffeinated beverages per day
• •Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 30 days or 5½ half-lives of the investigational product prior to the screening. The 30-day window will be derived from the date of the last study procedure (ie, poststudy, AE follow-up, etc.) in the previous study to the screening visit of the current study
• •Has a history of significant multiple and/or severe allergies \[including latex allergy, but with exception of seasonal rhinitis (hay fever)\] or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• •Has a known hypersensitivity to ibrexafungerp
• •Is currently a user including illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year
• •Is unable to abstain from strenuous exercise from the screening visit until administration of the initial dose of study drug, throughout the study until the poststudy visit