Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

Summary

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.

Timeline

Start

2021-08-27

Primary completion

2022-04-15

Completion

2022-04-15

Drugs

Indications