Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
Condition: Healthy Lactating Women
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open label, single treatment, 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 1 month 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).
    

Detailed description: 
      This is an open label, single treatment, 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 1 month 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).

      Subjects will be screened within 28 days prior to dosing. After informed consent is obtained,
      information from subjects will be collected (including maternal-related information) and
      subjects will undergo screening evaluations. Inclusion/exclusion criteria will be reviewed to
      determine the subject's eligibility at Screening. A lactation consultant will be available to
      provide lactation support to subjects once they are enrolled.

      Since the mother's infant cannot receive breast milk for 7 consecutive days (Day-1 to Day 6),
      the mother will be reminded at Screening to make plans to have their infant fed 7 consecutive
      days with either (a) formula or (b) stored breast milk (e.g., breast milk pumped and stored
      in the freezer during the screening period between the screening visit and the day of
      admission to inpatient unit).

      Subjects will be admitted to the inpatient unit on Day -1 to confirm eligibility. Subjects
      will receive 600 mg SPN-812 on the morning of Days 1, 2 and 3 after completion of safety
      assessments. SM should be administered at the same time in the morning (±30 min) of dosing
      days. Breast milk and blood sample for PK analysis will then be collected on Day 3 per
      schedule. Non-PK breast milk expressed on Days -1, 1, and 2 will be collected over the time
      intervals and these samples will not be analyzed for drug concentrations. The volume and the
      start and end times of the collection of each non-PK and PK breast milk sample will be
      recorded. The end of study (EOS) procedures will be conducted prior to discharge on Day 4
      following the last breast milk and blood sample collection. If subject discontinues early,
      all EOS procedures will be conducted.
    

Intervention name(s): SPN-812 (600mg, QD)
Intervention type(s): Drug
Intervention description(s): SPN-812 (600mg, QD)
Other intervention name(s): Viloxazine ER
Intervention MeSH terms: Viloxazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Lactating Women; Healthy Pregnancy