The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug. The study also aims to estimate the potential daily solriamfetol dose received by the infant from the breast milk of the nursing mother. The safety and tolerability of single oral doses of solriamfetol will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single-dose 150 mg tablet orally administered.
M3-Wake Research, Inc.
Raleigh, North Carolina, United States
Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and Plasma
The observed maximum breast milk and plasma concentrations (Cmax) of solriamfetol after administration.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Time to Reach Maximum Concentration (Cmax) (Tmax) in Breast Milk and Plasma
The time to reach the maximum breast milk and plasma concentrations (Tmax) of solriamfetol after administration.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Area Under the Concentration-Time Curve From Time 0 to the Time t of the Last Quantifiable Concentration (AUC 0-t) in Breast Milk and Plasma
The area under the plot of breast milk and plasma concentrations of solriamfetol against time after drug administration from predose (time 0) to Time t of the Last Quantifiable Concentration.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) in Breast Milk and Plasma
The area under the plot of breast milk and plasma concentrations of solriamfetol against time after drug administration from predose (time 0) to Infinity.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Apparent Elimination Half-Life (t^1/2) of Solriamfetol in Breast Milk and Plasma
The half-life or the period of time required for the concentration of solriamfetol in breast milk and plasma to be reduced to one-half of the administered amount.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Apparent Oral Clearance (CL/F) of Solriamfetol
Apparent oral clearance (CL/F) of solriamfetol in plasma.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Apparent Volume of Distribution (Vd/F) of Solriamfetol
Apparent volume of distribution (Vd/F) of solriamfetol in plasma.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Milk:Plasma Ratio
Area Under the concentration-time curve (AUC) in breast milk divided by AUC in plasma.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Amount Excreted in Breast Milk Over 72 Hours (Amilk)
The amount of solriamfetol excreted in breast milk samples over 72 hours.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Daily Infant Dose
Daily solriamfetol dose that may be received by the infant through breastfeeding.
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Relative Infant Dose
The percentage of the weight-adjusted maternal solriamfetol dose excreted in breast milk over 24 hours.
Time frame: Up to 24 hours post-dose.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that either began after first study drug dose or worsened after dosing.
Time frame: Predose (-2 to 0 hours) up to Days 9-11 post-dose.
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