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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: Completed Phase 4 study, sponsored by Supernus Pharmaceuticals.
NCT06259331 is a Phase 4 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Area under the concentration-time curve over a 24-hour dosing interval in breast milk for viloxazine and its metabolite 5-HVLX-gluc
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 |
What the finished NCT06259331 record still lists
NCT06259331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which SPN-812 (600mg, QD) is the first listed.
NCT06259331 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06259331's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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