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
This was a Phase 1 study designed to evaluate the pharmacokinetics of ibrexafungerp after administration of two oral doses in lactating women to determine whether ibrexafungerp is excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast milk and plasma of lactating women. Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H). Participants received both doses on site. Participants were admitted to the clinic on Day 1 and discharged on Day 5, after the 108-hour procedures were completed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
Ibrexafungerp Oral Tablet
Woodland Research Northwest (WRN)
Rogers, Arkansas, United States
SCY-078 Breast Milk Concentrations.
To determine the levels of SCY-078 in breast milk in ng/mL, starting pre-dose (Baseline) on Day 1 until 108 hours post first dose. Concentrations of SCY-078 in milk is measured pre-dose, and in milk collected at the following post-dose intervals: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours, 24-36 hours, 36-48 hours, 48-72 hours and 72-108 hours.
Time frame: Pre-dose up to 108 hours post first dose
SCY-078 Plasma Concentrations.
To measure the levels of SCY-078 in plasma at pre-dose (0 hours), 2, 6, 8 12 hours post dose (prior to the second dose) and 24, 36, 48, 72 and 108 hours post first dose.
Time frame: Pre-dose up to 72-108 hours post first dose
Potential Infant Exposure
The daily infant dosage (total drug present in milk and potentially consumed by the infant per day) is calculated using the following formula: Daily Infant Dosage (mg/day) = Σ (total drug concentration in each milk collection multiplied by the expressed milk volume in each milk collection)
Time frame: Day 1 of dosing (0-24 hours post dose)
Participants With Treatment Emergent Adverse Events (TEAEs)
Any participant who experiences a Treatment Emergent Adverse Event (TEAE).
Time frame: From the time of consent up to 108 hours post dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse events are reported for all participants in the study.
Time frame: From the time of consent up to 108 hours post-dose
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