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

Part of paid clinical trials in Raleigh, North Carolina.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT05008341
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 27, 2021
Status verified
Apr 2023
Primary completion
Apr 15, 2022
Completion
Apr 15, 2022

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Solriamfetol
    Participants will receive a single oral dose of solriamfetol 150 mg with 240 mL water at 0 hour on the morning of Day 1, 2 hours after completion of a light breakfast.

Primary Outcome Measure

Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and Plasma [ Time Frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose. ]

Locations (1)

FacilityCityStateZIPSite coordinators
M3-Wake Research, Inc.RaleighNorth Carolina27612-

Find similar trials in Raleigh, NC

By research site
M3-Wake Research, Inc.· Raleigh, NC

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