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

NCT05008341 | Completed Phase 1 FDA Drug

• 1 other identifier: JZP110-401
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Sunosi; Solriamfetol; Healthy Postpartum Women; Breast Milk; Plasma

Outcome Measures

Primary Outcomes (11)

• 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.

• 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.

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

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

Study Arms (1)

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.

Drug: Solriamfetol 150 mg Oral Tablet

Interventions

Solriamfetol 150 mg Oral Tablet DRUG

Single-dose 150 mg tablet orally administered.

Also known as: Sunosi®

Solriamfetol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Axsome Therapeutics, Inc.: lead

Study Sites (1)

M3-Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Related Links

• Axsome Therapeutics Website

MeSH Terms

Conditions

Narcolepsy; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence

Interventions

solriamfetol; Tablets

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: August 27, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

US (1)