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NCT06259331 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
A Phase 4 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT06259331 is a Phase 4 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 15 participants.
The verdict
NCT06259331, a Phase 4 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is an open label, single treatment, multiple doses lactation study of SPN-812 in healthy lactating women. The study is designed to assess the excretion of viloxazine and its major metabolite 5-HVLX-gluc into breast milk following repeated administration of SPN-812 600 mg, QD. This study is comprised of Screening, Inpatient Admission, Treatment Period and End of Study (EOS). The total duration of the study is up to 32 days including Screening up to 28 days and 4 days of Treatment Period. Subjects will remain in the inpatient unit for 5 days, including the day of admission to the inpatient unit (Day -1), 3 days of dosing SM (Days 1-3), and the day of discharge (Day 4).
Interventions
- DRUG SPN-812 (600mg, QD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-05-23 |
| Est. Completion | 2023-09-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06259331
The ClinicalTrials.gov registry entry for NCT06259331 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SPN-812 (600mg, QD) is the first listed.
NCT06259331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06259331 about?
NCT06259331 is a clinical study titled "Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women". This is an open label, single treatment, multiple doses lactation study of SPN-812 in healthy lactating women. The study is designed to assess the excretion of viloxazine and its major metabolite 5-HVLX-gluc into breast milk following repeated administration of SPN-812 600 mg, QD. This study is com...
What is the current status of trial NCT06259331?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2023-05-23. Estimated completion is 2023-09-20.
What interventions are being tested in trial NCT06259331?
The interventions under investigation include: SPN-812 (600mg, QD) (DRUG).
Who is sponsoring clinical trial NCT06259331?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
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