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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
158 studies on the registry are indexed under Narcolepsy; 38 are open to participants now.
Browse Narcolepsy studies →19 of the 85 studies in Narcolepsy with a site in United States are open now. Recruiting first, the newest first:
Suven Life Sciences Limited · Sites in United States
Ages 18+
Jazz Pharmaceuticals · Sites in United States
Ages 18–75
University of Utah · Sites in United States
Ages 18+
Takeda · Sites in United States, Australia, China and 4 more countries
Ages 18–70
Harmony Biosciences Management, Inc. · Sites in United States, Belgium, Canada and 4 more countries
Ages 18+
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 →
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.
85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 24 · Phase 3 24 · Phase 4 3
First in 1996; this study’s year is marked. 9 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 78 across 114 interventional studies indexed under Narcolepsy.
Median enrollment 93 across the 69 interventional studies, 191 across the 15 observational. Of the 62 that completed or were terminated, 30 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
66 of 85 have an industry lead sponsor. The 10 most frequent:
Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Axsome Therapeutics, Inc. has 5 studies filed under Narcolepsy — fewer than ten, so there is no comparison to draw.
11 of the studies in Narcolepsy with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07363720Phase 3TakedaA Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy | 2026-12-17 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07598708Phase 3Centessa Pharmaceuticals (UK) LimitedA Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence | 2027-09-30 |
| NCT07675135Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy | 2027-10 |
| NCT07540364Phase 3Suven Life Sciences LimitedA Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) | 2027-11-19 |
Add all 11 to your calendar (.ics) → With an account.
Among the 85 studies in Narcolepsy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Single-dose 150 mg tablet orally administered.
Also known as: Sunosi®
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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