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NCT05008341 · ClinicalTrials.gov registry record · Phase 1
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
A Phase 1 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05008341 is a Phase 1 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 6 participants.
The verdict
NCT05008341, a Phase 1 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DRUG Solriamfetol 150 mg Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2022-04-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05008341
The ClinicalTrials.gov registry entry for NCT05008341 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Solriamfetol 150 mg Oral Tablet is the first listed.
NCT05008341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05008341 about?
NCT05008341 is a clinical study titled "Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration". 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 t...
What is the current status of trial NCT05008341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-08-27. Estimated completion is 2022-04-15.
What interventions are being tested in trial NCT05008341?
The interventions under investigation include: Solriamfetol 150 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05008341?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
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