NarcolepsyPhase 1NCT05008341
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
A Phase 1 study testing Solriamfetol 150 mg Oral Tablet in people with Narcolepsy and Obstructive Sleep Apnea, run by Axsome Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence
- What is being tested?
- Solriamfetol 150 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 15 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adult female 18 to 50 years of age, inclusive, at the time of consent.
- Weigh at least 50 kg, and have a body mass index within 18 to 35 kg/m2 inclusive.
- 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.
- 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.
- 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.
- Have used a medically acceptable method of contraception 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.
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- Agree to comply with study-specified diet while in the study.
- Able to understand and comply with study requirements.
- Ensure that their breastfed infant(s) is able to feed from a bottle before study participation begins.
- 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.
Who cannot join
- Are pregnant.
- History of any illness, physical finding, laboratory examination or electrocardiogram (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.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition that may interfere with absorption, distribution, metabolism, or excretion of drugs.
- Estimated creatinine clearance of < 90 mL/min.
- History of breast implants, breast augmentation, or breast reduction surgery.
- Presence of mastitis or other condition that would prevent the collection of milk from one or both breasts.
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- Presence of active suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- History or presence of any clinically significant cardiovascular conditions.
- 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.
- 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.
- Unwilling to refrain from, or anticipates the use of, any medication, including prescription (with the exception of contraceptive 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.
- Use of a monoamine oxidase inhibitor within 14 days prior to Day 1 through the completion of breast milk collection and blood sampling.
- 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.
- Self-reported routine consumption of more than 600 mg of caffeine per day.
- Positive breath alcohol or urine drug screen (including cannabinoids) at screening or at any point throughout the duration of the study.
- Current or past (within the past 2 years) diagnosis of a moderate or severe substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Current or history (within the past 2 years) of seeking treatment for a substance related disorder.
- History or presence of phenylketonuria or a hypersensitivity or idiosyncratic reaction to phenylalanine-derived products, or any excipient in the formulated drug product.
- Has participated in another clinical trial of an investigational drug or medical device within 30 days or five half-lives (whichever is longer) prior to Day 1.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
M3-Wake Research, Inc.
Raleigh, North Carolina, 27612
About this study
Official title: A Phase 4, Open-Label, Single-Dose Study to Evaluate Sunosi® (Solriamfetol) Pharmacokinetics in Breast Milk and Plasma of Healthy Postpartum Women Following Oral Administration of Sunosi®
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.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness, Postpartum
- Being tested
- Solriamfetol 150 mg Oral Tablet
- Keywords
- Sunosi, Solriamfetol, Healthy Postpartum Women, Breast Milk, Plasma
- Medical subject headings
- Narcolepsy, Sleep Apnea, Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol 150 mg Oral TabletDrug
Also called Sunosi®
Single-dose 150 mg tablet orally administered.
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol | Experimental | 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. Receives: Drug: Solriamfetol 150 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and Plasma
The observed maximum breast milk and plasma concentrations (Cmax) of solriamfetol after administration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Predose (-2 to 0 hours) up to Days 9-11 post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start27 Aug 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008341
- Sponsor's protocol ID
- JZP110-401
- Status last verified
- Apr 2023
- First submitted
- 10 Aug 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label, Single-Dose Study to Evaluate Sunosi® (Solriamfetol) Pharmacokinetics in Breast Milk and Plasma of Healthy Postpartum Women Following Oral Administration of Sunosi®
- ClinicalTrials.gov ID
- NCT05008341
- Acronym / sponsor ID
- JZP110-401
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness, Postpartum
- Keywords
- Sunosi, Solriamfetol, Healthy Postpartum Women, Breast Milk, Plasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol | Experimental | Drug: Solriamfetol 150 mg Oral TabletParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy adult female 18 to 50 years of age, inclusive, at the time of consent.
- Weigh at least 50 kg, and have a body mass index within 18 to 35 kg/m2 inclusive.
- 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.
- 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.
- 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.
Key exclusion criteria (21 listed)
- Are pregnant.
- History of any illness, physical finding, laboratory examination or electrocardiogram (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.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition that may interfere with absorption, distribution, metabolism, or excretion of drugs.
- Estimated creatinine clearance of < 90 mL/min.
- History of breast implants, breast augmentation, or breast reduction surgery.
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 |
|---|---|---|
| Solriamfetol 150 mg Oral TabletAlso: Sunosi®Single-dose 150 mg tablet orally administered. | Drug | Solriamfetol |
Primary outcome
Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and Plasma
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
The observed maximum breast milk and plasma concentrations (Cmax) of solriamfetol after administration.
Time to Reach Maximum Concentration (Cmax) (Tmax) in Breast Milk and Plasma
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
The time to reach the maximum breast milk and plasma concentrations (Tmax) of solriamfetol after administration.
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
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
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.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) in Breast Milk and Plasma
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
The area under the plot of breast milk and plasma concentrations of solriamfetol against time after drug administration from predose (time 0) to Infinity.
Apparent Elimination Half-Life (t^1/2) of Solriamfetol in Breast Milk and Plasma
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
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.
Apparent Oral Clearance (CL/F) of Solriamfetol
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 in plasma.
Apparent Volume of Distribution (Vd/F) of Solriamfetol
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 in plasma.
Milk:Plasma Ratio
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 (AUC) in breast milk divided by AUC in plasma.
Amount Excreted in Breast Milk Over 72 Hours (Amilk)
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
The amount of solriamfetol excreted in breast milk samples over 72 hours.
Daily Infant Dose
Time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.
Daily solriamfetol dose that may be received by the infant through breastfeeding.
Relative Infant Dose
Time frame: Up to 24 hours post-dose.
The percentage of the weight-adjusted maternal solriamfetol dose excreted in breast milk over 24 hours.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Predose (-2 to 0 hours) up to Days 9-11 post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Solriamfetol 150 mg Oral Tablet in people with Narcolepsy and Obstructive Sleep Apnea, run by Axsome Therapeutics, 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 10 inclusion and 21 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 14 Apr 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and Plasma (time frame: Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2023.