Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259331
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2024-01-17
Brief Title:
Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
Sponsor:
Supernus Pharmaceuticals Inc
Organization:
Supernus Pharmaceuticals Inc
Study Overview
Official Title:
Evaluation of the Excretion of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk Following Multiple Doses of SPN-812 600mg QD in Healthy Lactating Women
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPN-812
Brief 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
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
Detailed Description:
This is an open label single treatment multiple doses lactation study of SPN-812 at steady state 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 daily for 3 days 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 End of Study EOS with FU phone call 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
Subjects will complete the screening visit after informed consent is obtained within 28 days prior to dose initiation Inclusionexclusion criteria will be reviewed to determine the subjects eligibility at Screening A lactation consultant will be available to provide lactation support to subjects once they are enrolled
Since the mothers 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 eg 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 in 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
This study is comprised of Screening Inpatient Admission Treatment Period End of Study EOS with FU phone call 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
Subjects will complete the screening visit after informed consent is obtained within 28 days prior to dose initiation Inclusionexclusion criteria will be reviewed to determine the subjects eligibility at Screening A lactation consultant will be available to provide lactation support to subjects once they are enrolled
Since the mothers 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 eg 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 in 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None