Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp (NCT06954493) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp
United States5 participantsStarted 2023-07-12
Plain-language summary
This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A healthy lactating woman aged 18 to 50 years, inclusive, at Screening
* At least 10-days postpartum after uncomplicated delivery with a full milk supply established. (There is no specific length of time postpartum)
* Actively breastfeeding or expressing breast milk
* willing to temporarily discontinue breast feeding their infant before the Day 1 morning dose through to 108 hours after the first dose (approximately 4.5 days) AND has the ability to pump breast milk and to provide a reserve for infant feeding, with acceptance of bottle feeding, prior to the study OR has decided to discontinue breastfeeding permanently but has not yet started weaning their infant with acceptance of bottle feeding and must have adequate milk supply
* Has a Body Mass Index (BMI) ≤34 kg/m2 at the screening visit. BMI is calculated by taking the participant's weight in kg and dividing by the participant's height in meters, squared.
* willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study
* Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests (all within laboratory normal ranges or changes outside the normal range judged to be clinically non-significant by the investigator) performed at the screening visit and prior to administration of the initial dose of study drug
* Has no clinically significant abnormality on electrocardiogram (ECG) …
What they're measuring
1
SCY-078 Breast Milk Concentrations.
Timeframe: Pre-dose up to 108 hours post first dose
2
SCY-078 Plasma Concentrations.
Timeframe: Pre-dose up to 72-108 hours post first dose