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Cohort 1 for Healthy Lactating Women (SPN-812 Trial)

Phase 4
Waitlist Available
Led By Ilmiya Brimhall, DO
Research Sponsored by Supernus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up breast milk pk day 3: -4 to <0 hrs pre-dose, and '0 to 4', '4 to 6', '6 to 8', '8 to 10', '10 to 12', '12 to 16' and '16 to 24' hrs post-dose, plasma pk day 3 pre-dose, and day 3 at 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 16.0 and 24.0-hrs post-dose
Awards & highlights

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).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~breast milk pk day 3: -4 to <0 hrs pre-dose, and '0 to 4', '4 to 6', '6 to 8', '8 to 10', '10 to 12', '12 to 16' and '16 to 24' hrs post-dose, plasma pk day 3 pre-dose, and day 3 at 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 16.0 and 24.0-hrs post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and breast milk pk day 3: -4 to <0 hrs pre-dose, and '0 to 4', '4 to 6', '6 to 8', '8 to 10', '10 to 12', '12 to 16' and '16 to 24' hrs post-dose, plasma pk day 3 pre-dose, and day 3 at 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 16.0 and 24.0-hrs post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUCtau,Milk
Cave,Milk
Cmax,Milk
+2 more
Secondary study objectives
Breast Milk-plasma Ratio (ML/PL)
Daily Infant Dosage (DID)
Estimated Daily Infant Dosage (EDID, mg/kg/Day)
+8 more

Side effects data

From 2023 Phase 4 trial • 15 Patients • NCT06259331
67%
somnolence
20%
breast tenderness
20%
nausea
20%
dizziness
13%
headache
13%
dry mouth
7%
hot flush
7%
dyspepsia
7%
decreased appetite
7%
dermatitis
7%
chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cohort 1Experimental Treatment1 Intervention
Up to 15 healthy, lactating women will be enrolled in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPN-812 (600mg, QD)
2023
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
13,877 Total Patients Enrolled
Darian Yarullina, MDStudy DirectorAssistant Director, Drug Safety and Medical Monitoring
Ilmiya Brimhall, DOPrincipal InvestigatorPPD Phase I Clinic
~7 spots leftby Sep 2025
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