Pharmacokinetics of Oral Zoliflodacin 3 g in Healthy Lactating Women

Inclusion Criteria:

• Woman with good general health status, as determined by medical history, physical examination, laboratory tests, vital signs, and clinical judgment at Screening and check-in
• Age ≥18 to ≤45 years at the time of signing the informed consent
• Weight ≥50 kg at Screening and check-in
• Given birth to a single, healthy, clinically stable, full-term (37 to 42 weeks' gestation) infant in the past 6 weeks to 24 months before Day 1
• Agrees to not breastfeed her infant from check-in until 72 hours after zoliflodacin administration
• Has well-established lactation (ie, at least 4 weeks postpartum) and is breastfeeding her infant; supplemental infant formula use is allowable, and the extent of use of formula will be documented
• Has confirmed that her breastfed infant is able to feed from a bottle
• Agrees to collect all breast milk from predose through 2 days after the trial drug administration using an electric pump
• Has a negative pregnancy test at Screening and check-in
• Has sufficient venous access to allow for collection of plasma samples
• Agrees to use a highly effective form of contraception (see Section 5.4) with male sexual partners during the trial and for at least 28 days after the zoliflodacin dose
• Agrees to comply with all protocol requirements
• Agrees not to participate in other research trials involving investigational medication or medical devices for the duration of this trial
• Provides written informed consent

Exclusion Criteria:

• History of breast implants, breast augmentation, or breast reduction surgery that, in the investigator's opinion, may have a clinical impact on breast milk expression
• Evidence of acute or chronic condition that, in the investigator's opinion, may have a clinical impact on breast milk expression
• Active mastitis within 30 days before Day 1
• Current breast abscess or cracked/bleeding nipples
• History of inadequate lactation
• Moderate or severe hepatic or renal impairment, or other clinically significant medical condition that, in the investigator's opinion, might affect zoliflodacin PK or participant safety
• Known hypersensitivity to zoliflodacin or formulation excipients
• Positive pregnancy test at Screening or check-in
• Positive NAAT result for N gonorrhoeae at Screening
• Positive serologic test for HIV-1 or HIV-2 antibody, hepatitis B surface antigen, or hepatitis C antibody at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, and negative hepatitis B surface antigen) may be included
• Use of zoliflodacin within 30 days before Day 1
• Use of a moderate or strong inducer or inhibitor of CYP3A4, P-glycoprotein, BCRP, or OATP transporters within 14 days or 5 half-lives, whichever is longer, before Day 1
• Consumption of grapefruit, grapefruit juice, or similar citrus fruits (like Seville oranges and pomelos) within 14 days before Day 1
• Current use of tobacco or nicotine-containing products
• Known or suspected drug abuse
• A positive drug or alcohol screen result at Screening or on Day -1
• Participants must not donate blood within 30 days or donate plasma within 7 days before Day 1
• Participation in an interventional clinical trial within 30 days or 5 half-lives of the trial drug, whichever is longer, before Day 1
• Any condition or circumstance that, in the investigator's judgment, may pose a risk to the participant or interfere with protocol adherence (including the 72-hour breastfeeding interruption), assessment of trial objectives, or ability to provide informed consent