Healthy Lactating WomenPhase 4SPN-812NCT06259331
Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
A Phase 4 study testing SPN-812 (600mg, QD) in people with Healthy Lactating Women, run by Supernus Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Lactating Women
- What is being tested?
- SPN-812 (600mg, QD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 20 Sep 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy lactating females, 18 to 45 years of age, who are actively breastfeeding (including baby to breast, bottle feeding mother's expressed breast milk) and are at least 12 weeks postpartum of a healthy term newborn infant (no medical complications) and not more than 2 years postpartum. Lactation must be well established and the mother is exclusively breast feeding her baby (not providing supplemental formula) prior to the day of admission to inpatient unit.
- Has a body mass index between 18 to 35 kg/m2, included.
- Is considered medically healthy by the Investigator via assessment of physical examination (neurological examinations included), medical history, clinical laboratory tests, vital signs, Columbia-Suicide Severity Rating Scale (C-SSRS) and electrocardiogram (ECG).
- Is willing to temporarily discontinue breastfeeding their infant and discard all their breast milk for 7 consecutive days, including day of admission to inpatient unit (Day -1), 3 consecutive days of dosing SM while in the inpatient unit (Days 1 to 3), and 3 consecutive days after last dose of SM (including day of discharge from the inpatient unit and 2 days at home; Days 4 to 6); and willing to store sufficient amount of breast milk (e.g., breast milk pumped and stored in freezer before the day of admission), and/or infant formula to feed infant during these 7 consecutive days.
- Is either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the following acceptable birth control methods beginning during the screening period prior to the first dose of SM, throughout the inpatient study, and for 3 days following the last dose of SM (Day 3):
- intra-uterine contraceptive device;
Show all 16Show fewer
- barrier method: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- is surgically sterile or male partner is surgically sterile;
- established use of a patch, vaginal ring, oral, injected or implanted hormonal methods of contraception that can be used in lactating women;
- Essure® procedure performed at least 6 months prior to Screening and had hysterosalpingogram after the Essure procedure to document tubal occlusion prior to screening.
- Must not be in the process of weaning before admission and have maintained an adequate breast milk supply with regularly pumping or routine breastfeeding (e.g., pumping or feeding 3-4 times a day) at admission.
- Is currently a non-smoker who has not used tobacco or nicotine-containing products (chewed or smoked) or replacement products, including electronic cigarettes, within 3 months prior to screening and a negative cotinine test result at Screening.
- Agrees to use only the emollient or nipple cream recommended by the investigator for use during the sampling period, if needed.
- Able to voluntarily provide written informed consent to participate in the study.
- Able to understand and willing to comply with all study requirements.
- Able and willing to swallow capsules whole, without crushing, chewing, or cutting.
Who cannot join
- Participation in any other investigational study drug trial in which receipt of an investigational study drug within 30 days or 5 half-lives before Screening, whichever is longer.
- Is unwilling or unable to comply with the Lifestyle guidelines presented in the protocol during the study period.
- Has history or presence of clinically significant systemic disease (including psychological and psychiatric disorders).
- Is currently using, or tests positive at Screening for cotinine, alcohol, or drugs (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, PCP, benzodiazepines, and THC/cannabis).
- Is pregnant (has positive serum pregnancy test at Screening) or becomes pregnant during study (has positive urine pregnancy test).
- Has history of breast implants, breast augmentation, or breast reduction surgery.
Show all 27Show fewer
- Has history of mastitis within 30 days, breast cancer and/or has had a mastectomy or lumpectomy with the exception of a benign fibroma or lipoma removal at the investigator's discretion; and/or a clinically significant abnormality observed in either breast during a clinical breast exam at Screening or Admission (Day -1).
- Has a history of alcohol use disorder within 1 year of Screening; or assessed by the PI as having regularly consumed alcohol exceeding 14 units per week (1 unit equals 340 mL of beer, 115 mL of wine, or 43 mL of spirits) within 1 year of Screening.
- Is using recreational or illicit drug(s) (e.g., cannabis /tetrahydrocannabinol (THC), opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, and benzodiazepines) within 1 year of Screening.
- Has clinically significant vital signs abnormalities (systolic blood pressure less than 90 or greater than 140 mmHg, diastolic blood pressure less than 60 or greater than 90 mmHg, or pulse rate (PR) less than 50 or greater than 100 bpm at Screening.
- Has a clinical laboratory test values outside the reference range at Screening that, in the opinion of the investigator, are clinically significant, or any of the following:
- Serum creatinine >1.5 times the upper limit of normal (ULN)
- Serum total bilirubin >1.5 times ULN
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times ULN
- Has clinically significant ECG abnormalities at Screening, including:
- PR interval >220 ms
- QRS interval >130 ms
- QTcF interval >470 ms
- Has any disease or medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or interfere with the conduct or interpretation of the study.
- Has evidence of infection with hepatitis B and C, and human immunodeficiency virus HIV-1 and HIV-2, as determined by results of testing at Screening.
- Has a condition or planned procedure that may interfere with the absorption, metabolism, or elimination of the study drug (e.g., cholecystectomy).
- Is using prescription medication within 14 days prior to administration of SM or 5 half-lives, whichever is longer, with the exception of hormonal contraceptives.
- Is using over-the-counter products (including vitamins, herbal products and natural food supplements) within 14 days prior to administration of SM or 5 half-lives, whichever is longer. Exceptions include postnatal vitamins, topical products without systemic absorption and acetaminophen (< 2 g/day).
- Has an allergy to viloxazine.
- Has an Edinburgh Postnatal Depression Scale score >13.
- Has attempted suicide within the 6 months prior to Screening or is at significant risk of suicide (either in the opinion of the Investigator or defined as a "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the 12 months prior to screening).
- In the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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. 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 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.
- Conditions
- Healthy Lactating Women
- Being tested
- SPN-812 (600mg, QD)
- Keywords
- Healthy Lactating Women, Healthy Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPN-812 (600mg, QD)Drug
Viloxazine ER
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Up to 15 healthy, lactating women will be enrolled in the study. Receives: Drug: SPN-812 (600mg, QD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau,Milk
Area under the concentration-time curve over a 24-hour dosing interval in breast milk for viloxazine and its metabolite 5-HVLX-gluc
Measured: Day 3: -4 to <0 hours 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' hours post-dose.
Cmax,Milk
Maximum observed concentration in breast milk for viloxazine and its metabolite 5-HVLX-gluc
Measured: -4 to <0 hours 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' hours post-dose.
Tmax,Milk
time of maximum observed concentration in breast milk for viloxazine and its metabolite 5-HVLX-gluc
Measured: Day 3: -4 to <0 hours 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' hours post-dose.
Ctrough,Milk
Observed drug concentration in milk immediately before the next dose for viloxazine and its metabolite 5-HVLX-gluc
Measured: Day 3: -4 to <0 hours 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' hours post-dose.
Cave,Milk
Average drug concentration in milk, calculated as the ratio of AUCtau,milk/24 for viloxazine and its metabolite 5-HVLX-gluc
Measured: Day 3: -4 to <0 hours 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' hours post-dose.
Secondary outcomes (11)
Plasma AUCtau,ss
Area under the concentration-time curve over the dosing interval (AUCtau) in plasma for viloxazine and its metabolite 5-HVLX-gluc at steady-state
Measured: 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-hours post-dose.
Plasma Cmax,ss,
Maximum observed concentration in plasma for viloxazine and its metabolite 5-HVLX-gluc
Measured: 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-hours post-dose.
Plasma Tmax,ss
Time to Peak Concentration
Measured: 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-hours post-dose.
Plasma CL/Fss,
Apparent clearance (Dose/AUCtau,ss)
Measured: 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-hours post-dose.
Plasma Cave,ss
Average plasma concentration, calculated as the ratio of AUCtau,ss/24
Measured: 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-hours post-dose.
Plasma Ctrough,ss
Observed plasma concentration immediately before the next dose
Measured: 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-hours post-dose.
Breast Milk-plasma Ratio (ML/PL)
Breast milk-plasma ratio (ML/PL) based on AUC over 24 hours for viloxazine and 5-HVLX-gluc at plasma steady-state. Ratio of AUCtau from milk to AUCtau from plasma (CV%)
Measured: 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
Estimated Daily Infant Dosage (EDID, mg/kg/Day)
Estimated daily infant dosage (mg/kg/day) calculated as Milk/Plasma Ratio x the average maternal plasma concentration (Cave,ss) multiplied by 150 mL/kg/day (EDID 150) and 200 mL/kg/day (EDID 200), respectively.
Measured: 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
Relative Infant Dose (RID, %) at Plasma Steady-state
Relative infant dose (%); the percent of the weight-adjusted maternal dosage consumed in breast milk over 24 hours, calculated as EDID (mg/kg/day)/maternal dosage (mg/kg/day) multiplied by 100 %.
Measured: 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
Daily Infant Dosage (DID)
Daily infant dosage (mg/day); total drug present in breast milk and consumed by the infant per day, which is equal to AM,milk.
Measured: 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
Number of Participants With Adverse Events (AEs)
All subjects who are enrolled and who receive SM will be monitored and questioned regarding the occurrence of AEs. Adverse events occurring prior to SM administration on Study Day 1 will become part of the subject's medical history. Throughout the study, the Investigator must seek information on AEs by specific questioning and, as appropriate, by examination.
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start23 May 2023
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Lactating WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cai, Study director, Clinical PharmacologyDarin B Brimhall, DO, Principal investigator, PPD Phase I Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259331
- Sponsor's protocol ID
- 812P418
- Acronym
- SPN-812
- Status last verified
- Jun 2024
- First submitted
- 17 Jan 2024
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cai Y, Wang Z, Alleyne N, Earnest J, Lin M, Upadhyaya H. Pharmacokinetics of Viloxazine ER (Viloxazine Extended-Release Capsules) in Breast Milk of Healthy Lactating Women. J Clin Psychiatry. 2026 Aug 5;87(3):25m16169. doi: 10.4088/JCP.25m16169.
PubMed 42555253
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06259331
- Acronym / sponsor ID
- SPN-812 / 812P418
- Conditions
- Healthy Lactating Women
- Keywords
- Healthy Lactating Women, Healthy Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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. 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 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SPN-812 (600mg, QD)Up to 15 healthy, lactating women will be enrolled in the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy lactating females, 18 to 45 years of age, who are actively breastfeeding (including baby to breast, bottle feeding mother's expressed breast milk) and are at least 12 weeks postpartum of a healthy term newborn infant (no medical complications) and not more than 2 years postpartum. Lactation must be well established and the mother is exclusively breast feeding her baby (not providing supplemental formula) prior to the day of admission to inpatient unit.
- Has a body mass index between 18 to 35 kg/m2, included.
- Is considered medically healthy by the Investigator via assessment of physical examination (neurological examinations included), medical history, clinical laboratory tests, vital signs, Columbia-Suicide Severity Rating Scale (C-SSRS) and electrocardiogram (ECG).
- Is willing to temporarily discontinue breastfeeding their infant and discard all their breast milk for 7 consecutive days, including day of admission to inpatient unit (Day -1), 3 consecutive days of dosing SM while in the inpatient unit (Days 1 to 3), and 3 consecutive days after last dose of SM (including day of discharge from the inpatient unit and 2 days at home; Days 4 to 6); and willing to store sufficient amount of breast milk (e.g., breast milk pumped and stored in freezer before the day of admission), and/or infant formula to feed infant during these 7 consecutive days.
- Is either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the following acceptable birth control methods beginning during the screening period prior to the first dose of SM, throughout the inpatient study, and for 3 days following the last dose of SM (Day 3):
Key exclusion criteria (27 listed)
- Participation in any other investigational study drug trial in which receipt of an investigational study drug within 30 days or 5 half-lives before Screening, whichever is longer.
- Is unwilling or unable to comply with the Lifestyle guidelines presented in the protocol during the study period.
- Has history or presence of clinically significant systemic disease (including psychological and psychiatric disorders).
- Is currently using, or tests positive at Screening for cotinine, alcohol, or drugs (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, PCP, benzodiazepines, and THC/cannabis).
- Is pregnant (has positive serum pregnancy test at Screening) or becomes pregnant during study (has positive urine pregnancy test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPN-812 (600mg, QD)Viloxazine ER | Drug | Cohort 1 |
Primary outcome
AUCtau,Milk
Time frame: Day 3: -4 to <0 hours 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' hours post-dose.
Area under the concentration-time curve over a 24-hour dosing interval in breast milk for viloxazine and its metabolite 5-HVLX-gluc
Cmax,Milk
Time frame: -4 to <0 hours 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' hours post-dose.
Maximum observed concentration in breast milk for viloxazine and its metabolite 5-HVLX-gluc
Tmax,Milk
Time frame: Day 3: -4 to <0 hours 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' hours post-dose.
time of maximum observed concentration in breast milk for viloxazine and its metabolite 5-HVLX-gluc
Ctrough,Milk
Time frame: Day 3: -4 to <0 hours 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' hours post-dose.
Observed drug concentration in milk immediately before the next dose for viloxazine and its metabolite 5-HVLX-gluc
Cave,Milk
Time frame: Day 3: -4 to <0 hours 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' hours post-dose.
Average drug concentration in milk, calculated as the ratio of AUCtau,milk/24 for viloxazine and its metabolite 5-HVLX-gluc
11 secondary outcomes
Plasma AUCtau,ss
Time frame: 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-hours post-dose.
Plasma Cmax,ss,
Time frame: 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-hours post-dose.
Plasma Tmax,ss
Time frame: 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-hours post-dose.
Plasma CL/Fss,
Time frame: 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-hours post-dose.
Plasma Cave,ss
Time frame: 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-hours post-dose.
Plasma Ctrough,ss
Time frame: 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-hours post-dose.
Breast Milk-plasma Ratio (ML/PL)
Time frame: 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
Estimated Daily Infant Dosage (EDID, mg/kg/Day)
Time frame: 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
Relative Infant Dose (RID, %) at Plasma Steady-state
Time frame: 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
Daily Infant Dosage (DID)
Time frame: 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
Number of Participants With Adverse Events (AEs)
Time frame: 11 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42555253Cai Y, Wang Z, Alleyne N, Earnest J, Lin M, Upadhyaya H. Pharmacokinetics of Viloxazine ER (Viloxazine Extended-Release Capsules) in Breast Milk of Healthy Lactating Women. J Clin Psychiatry. 2026 Aug 5;87(3):25m16169. doi: 10.4088/JCP.25m16169.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Cai study director
Clinical Pharmacology
Darin B Brimhall, DO principal investigator
PPD Phase I Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SPN-812 (600mg, QD) in people with Healthy Lactating Women, run by Supernus Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCtau,Milk (time frame: Day 3: -4 to <0 hours 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' hours post-dose.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06259331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.