ClinicalTrials.gg
CompletedNCT05008341Updated Apr 14, 2023

Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

A Phase 1 interventional study of Solriamfetol 150 mg Oral Tablet in Narcolepsy, Obstructive Sleep Apnea and Excessive Daytime Somnolence, sponsored by Axsome Therapeutics, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Axsome Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2022, 4 years 7 months ago, and no results have been posted to the registry.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 85 studies in Narcolepsy with a site in United States — 19 open to participants now, 20 under way, 8 of them phase 3. Narcolepsy · United States.

Enrollment
67th of 69
6 · median 93
Started
2021
with 8 others
Phase 1
13 of 85
1 open now
Registered
47th of 85
by date
Lead sponsor
5 of 85
Axsome Therapeutics, Inc.

Among the 85 studies in Narcolepsy with a site in United States, this one is the 67th largest by enrollment of the 69 interventional ones that give a count, is one of 9 that started in 2021, is one of 13 in phase 1, and was the 47th registered.

Narcolepsy

158 studies on the registry are indexed under Narcolepsy; 38 are open to participants now.

Browse Narcolepsy studies →

Open to participants now

19 of the 85 studies in Narcolepsy with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 19 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 30 Narcolepsy studies recruiting now, 12 (40%) set no upper age limit and 16 (53%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.

This study: 18 Years to 50 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 85 studies in Narcolepsy with a site in United States, or all of them as a file.
02

Study summary

The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug. The study also aims to estimate the potential daily solriamfetol dose received by the infant from the breast milk of the nursing mother. The safety and tolerability of single oral doses of solriamfetol will also be assessed.

03

Conditions studied

  • Narcolepsy
  • Obstructive Sleep Apnea
  • Excessive Daytime Somnolence
  • Excessive Sleepiness
  • Postpartum

Keywords

  • Sunosi
  • Solriamfetol
  • Healthy Postpartum Women
  • Breast Milk
  • Plasma
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult female 18 to 50 years of age, inclusive, at the time of consent.
  2. Weigh at least 50 kg, and have a within 18 to 35 kg/m2 inclusive.
  3. Between 10 days and 52 weeks postpartum, inclusive, after delivery of a normal, healthy infant by the time of dosing, and actively lactating from both breasts.
  4. If breastfeeding, agree to withhold breastfeeding their infant(s) from approximately 2 hours before dosing to approximately 72 hours after dosing and resume breastfeeding after completion of study Day 4 procedures OR have made a decision to wean their infant(s) before enrollment in the study.
  5. Agree not to use nicotine-containing products including tobacco (cigarettes, cigars, chewing tobacco, snuff), e-cigarettes, and nicotine lozenge/gum/patch within 3 days prior to check-in on Day -1, and for the duration of the study.
  6. Have used a medically acceptable method of for at least the 2 months prior to dosing on Day 1, and consent to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the study is completed.
  7. Agree to comply with study-specified diet while in the study.
  8. Able to understand and comply with study requirements.
  9. Ensure that their breastfed infant(s) is able to feed from a bottle before study participation begins.
  10. Agree to ensure nutrition is available for their infant(s) through stored breast milk, or alternative nutritional sources as necessary, for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Are pregnant.
  2. History of any illness, physical finding, laboratory examination or (ECG) finding that, in the opinion of the investigator, might confound the results or conduct of the study or pose a risk to the participant.
  3. History or presence of gastrointestinal, hepatic, or renal disease or any other condition that may interfere with absorption, distribution, metabolism, or excretion of drugs.
  4. Estimated of \< 90 mL/min.
  5. History of breast implants, breast augmentation, or breast reduction surgery.
  6. Presence of mastitis or other condition that would prevent the collection of milk from one or both breasts.
  7. Presence of active suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
  8. History or presence of any cardiovascular conditions.
  9. Resting supine systolic blood pressure > 140 mmHg or \< 90 mmHg or supine diastolic blood pressure > 90 mmHg or \< 50 mmHg at the Screening Visit or at predose on Day 1. Blood pressure measurement may be repeated once at the discretion of the investigator.
  10. Resting supine pulse rate of \< 45 beats per minute (bpm) or >100 bpm at the Screening Visit or at predose on Day 1. Pulse rate measurement may be repeated once at the discretion of the investigator.
  11. Unwilling to refrain from, or anticipates the use of, any medication, including prescription (with the exception of agents) and non-prescription drugs (with the exception of acetaminophen no more than 2600 mg a day and ibuprofen no more than 1200 mg a day), antacids, vitamin supplements, or herbal remedies, beginning 14 days or 5 half-lives (whichever is longer) prior to Day 1 through the completion of breast milk collection and blood sampling.
  12. Use of a monoamine oxidase inhibitor within 14 days prior to Day 1 through the completion of breast milk collection and blood sampling.
  13. Unwilling to abstain from alcohol or caffeine/xanthine-containing products, including coffee, tea, chocolate, and cola, within 48 hours prior to Day 1 through the completion of breast milk collection and blood sampling.
  14. Self-reported routine consumption of more than 600 mg of caffeine per day.
  15. Positive breath alcohol or urine drug screen (including cannabinoids) at screening or at any point throughout the duration of the study.
  16. Current or past (within the past 2 years) diagnosis of a moderate or severe substance use disorder according to , 5th Edition (DSM-5) criteria.
  17. Current or history (within the past 2 years) of seeking treatment for a substance related disorder.
  18. History or presence of phenylketonuria or a or idiosyncratic reaction to phenylalanine-derived products, or any in the formulated drug product.
  19. Has participated in another clinical trial of an drug or medical device within 30 days or five half-lives (whichever is longer) prior to Day 1.
  20. Any other condition that would cause a risk to the participant if they participate in the trial, or to the ability of the participant to complete the study, based on the judgement of the investigator.
  21. Employee of the study unit or Jazz Pharmaceuticals, anyone involved in the conduct of the trial, and first- and second-degree family member of anyone involved in the conduct of the trial.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Solriamfetol

    Participants will receive a single oral dose of solriamfetol 150 mg with 240 mL water at 0 hour on the morning of Day 1, 2 hours after completion of a light breakfast.

    Drug: Solriamfetol 150 mg Oral Tablet

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and Plasma

    The observed maximum breast milk and plasma concentrations (Cmax) of solriamfetol after administration.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  2. Time to Reach Maximum Concentration (Cmax) (Tmax) in Breast Milk and Plasma

    The time to reach the maximum breast milk and plasma concentrations (Tmax) of solriamfetol after administration.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  3. Area Under the Concentration-Time Curve From Time 0 to the Time t of the Last Quantifiable Concentration (AUC 0-t) in Breast Milk and Plasma

    The area under the plot of breast milk and plasma concentrations of solriamfetol against time after drug administration from predose (time 0) to Time t of the Last Quantifiable Concentration.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  4. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) in Breast Milk and Plasma

    The area under the plot of breast milk and plasma concentrations of solriamfetol against time after drug administration from predose (time 0) to Infinity.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  5. Apparent Elimination Half-Life (t^1/2) of Solriamfetol in Breast Milk and Plasma

    The half-life or the period of time required for the concentration of solriamfetol in breast milk and plasma to be reduced to one-half of the administered amount.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  6. Apparent Oral Clearance (CL/F) of Solriamfetol

    Apparent oral clearance (CL/F) of solriamfetol in plasma.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  7. Apparent Volume of Distribution (Vd/F) of Solriamfetol

    Apparent volume of distribution (Vd/F) of solriamfetol in plasma.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  8. Milk:Plasma Ratio

    Area Under the concentration-time curve (AUC) in breast milk divided by AUC in plasma.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  9. Amount Excreted in Breast Milk Over 72 Hours (Amilk)

    The amount of solriamfetol excreted in breast milk samples over 72 hours.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  10. Daily Infant Dose

    Daily solriamfetol dose that may be received by the infant through breastfeeding.

    Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.

  11. Relative Infant Dose

    The percentage of the weight-adjusted maternal solriamfetol dose excreted in breast milk over 24 hours.

    Time frame: Up to 24 hours post-dose.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that either began after first study drug dose or worsened after dosing.

    Time frame: Predose (-2 to 0 hours) up to Days 9-11 post-dose.

07

Study locations

1 site
  • M3-Wake Research, Inc.
    Raleigh, North Carolina 27612, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Apr 2022, 7 months.

Of 13 phase 1 interventional studies under Narcolepsy, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2021
First posted
Aug 17, 2021
StartActual
Aug 27, 2021
Primary completionActual
Apr 15, 2022
CompletionActual
Apr 15, 2022
Last update
Apr 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05008341
Responsible party
Sponsor
First posted
Aug 17, 2021
Start date
Aug 27, 2021
Primary completion
Apr 15, 2022
Completion
Apr 15, 2022
Last update
Apr 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Solriamfetol

Start the discussion