The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: * to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. * to measure the concentration and characterize the pharmacokinetics of BMT secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. This open-label, pharmacokinetic (PK) study will be performed in 10 healthy lactating female subjects between 10 days and 6 months post-partum (inclusive). The maximum duration of subject participation in the study will be approximately 29 days, consisting of 3-week Screening period, a 1 day treatment period, and up to a 7 day follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Single dose of BMT 1.75 mg SC on Day 1
First Excellence Research Group LLC
Doral, Florida, United States
Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi
The levels/concentrations of bremelanotide (BMT) will be measured in breast milk samples collected at different timepoints up to 24h from lactating women who receive a single dose of Vyleesi (BMT 1.75 mg SC).
Time frame: 24 hours
Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Breast Milk
Time frame: 24 hours
Maximum observed concentration (Cmax) of BMT in breast milk
Time frame: 24 hours
Time to reach Cmax of BMT in breast milk (Tmax)
Time frame: 24 hours
Terminal half-life of BMT in breast milk (t1/2)
Time frame: 24 hours
Levels of Bremelanotide (BMT) in Plasma Over 24h After Administration of Vyleesi
Time frame: 24 hours
Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Plasma
Time frame: 24 hours
Maximum observed concentration (Cmax) of BMT in Plasma
Time frame: 24 hours
Time to reach Cmax of BMT in Plasma (Tmax)
Time frame: 24 hours
Milk:plasma ratio (M/P) of BMT Levels
Time frame: 24 hours
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