The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding. The study is seeking for about 12 healthy breast-feeding females who are: * 18 to 55 years of age. * actively breast-feeding or producing breast milk. * at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose. Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
intransal spray 10mg
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinicals Applications LLC DBA QPS-MO Patient Screening and Recruitment Center Center)
Springfield, Missouri, United States
Area Under the Breast Milk Concentration-time Profile from time 0 extrapolated to infinite time (AUCinf), if data permit
AUCinf = Area under the breast milk concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Area under the breast milk concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of 24 hr post dose (AUC24)
AUC24= Area under the breast milk concentration versus time curve from time zero (pre-dose) to time 24 hours
Time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Maximum observed breast milk concentration (Cmax)
Time frame: 0 to 24 hours post dose
Time for Cmax in Breast Milk (Tmax)
Time frame: 0 to 24 hours post dose
Terminal half-life for breast milk (t 1/2), if data permit
Time frame: 0 to 24 hours post dose
Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf), if data permit
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0 to 24 hours post dose
Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0 to 24 hours post dose
Area under the concentration-time profile from time 0 to 24 hours post dose (AUC24)
AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours
Time frame: 0 to 24 hours post dose
Maximum observed plasma concentration (Cmax)
Time frame: 0 to 24 hours post dose
Time for plasma Cmax (Tmax)
Time frame: 0 to 24 hours post dose
Plasma Terminal half-life (t 1/2), if data permit
Time frame: 0 to 24 hours post dose
Average plasma concentration (Cav) over 24 hr
Time frame: 0 to 24 hours post dose
Breast milk to plasma ratio for AUCinf (MPAUCinf), if data permit
Time frame: 0 to 24 hours post dose
Breast milk to plasma ratio (MPAUC24) for AUC24, if data permit
Time frame: 0 to 24 hours post dose
Breast milk to plasma ratio for Cmax (MPCmax)
Time frame: 0 to 24 hours post dose
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to at least 28 days after last dose of study drug
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: 0 to 24 hours post dose
Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters
Time frame: 0 to 24 hours post dose
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: 0 to 24 hours post dose
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