NCT05008341

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

A Phase 4, Open-Label, Single-Dose Study to Evaluate Sunosi® (Solriamfetol) Pharmacokinetics in Breast Milk and Plasma of Healthy Postpartum Women Following Oral Administration of Sunosi®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Narcolepsy
• Obstructive Sleep Apnea
• Excessive Daytime Somnolence
• Excessive Sleepiness
• Postpartum

Interventions

Type	Name	Description
DRUG	Solriamfetol 150 mg Oral Tablet	Single-dose 150 mg tablet orally administered.

Timeline

• Start date: 2021-08-27
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2021-08-17
• Last updated: 2023-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study