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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solriamfetol 150 mg Oral Tablet | Drug | Single-dose 150 mg tablet orally administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and Plasma | The observed maximum breast milk and plasma concentrations (Cmax) of solriamfetol after administration. | 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. | 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. | 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. | 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. | Predose, 1, 1.5, 3, 6, 8.5, 10, 13, 15, 21, 24, 28, 36, 44, and 72 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose (-2 to 0 hours) up to Days 9-11 post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M3-Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
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| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
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| Apparent Oral Clearance (CL/F) of Solriamfetol | Apparent oral clearance (CL/F) of solriamfetol in plasma. | 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. | 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. | 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. | 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. | 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. | Up to 24 hours post-dose. |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D020181 | Sleep Apnea, Obstructive |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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