| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10021235 |
| E.1.2 | Term | Idiopathic narcolepsy |
| E.1.2 | System Organ Class | 100000004852 |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To characterize the pharmacokinetics (PK) of single doses of solriamfetol in pediatric subjects with narcolepsy. |
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| E.2.2 | Secondary objectives of the trial |
| To assess the safety and tolerability of single doses of solriamfetol in pediatric subjects with narcolepsy. |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Male and female subjects 6 to < 18 years old at Screening, depending on Group.
2. Minimum body weight of 22 kg.
3. Subjects with diagnosis of narcolepsy according to International Classification of Sleep Disorders-3 (ICSD-3) criteria, or, with the permission of the medical monitor, completed a Multiple Sleep Latency Test (MSLT) during Screening to confirm the diagnosis of narcolepsy by ICSD-3 criteria (ie, the subject met all other ICSD-3 criteria for narcolepsy). 4. Subjects with documented written assent per institutional review board (IRB) / ethics committee (EC) requirements indicating that he/she is aware of the investigational nature of the study and the required procedures and restrictions before participation in any protocol-related activities.
5. Parent(s)/guardian(s) must give their written informed consent for his/her/their child’s participation in the study.
6. Female subjects of childbearing potential (ie, fertile, following menarche) and male subjects who have female partners of childbearing potential must agree to use medically acceptable methods of contraception with their partners from Screening, throughout the study, and for 30 days after the last dose of solriamfetol. Medically acceptable methods of contraception that may be used by the subject include abstinence (when this is in line with the preferred and usual lifestyle of the subject), progestogenonly oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, and a combination of a male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods). Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, single barrier methods (male or female condom with or without spermicide; cap, diaphragm, or sponge with spermicide), and lactational amenorrhoea method (LAM) are not acceptable methods of contraception for this study. Female condom and male condom should not be used together.
7. Subjects must agree to abstain from alcohol and nicotine-containing products; including tobacco (eg, cigarettes, cigars, chewing tobacco, snuff), e-cigarettes, and nicotine lozenge/gum/patch within 3 days prior to each dosing in Periods 1, 2, and 3 through discharge from that period.
8. Subjects must agree to discontinue use of over-the-counter (OTC) or prescription stimulants (eg, pseudoephedrine, methylphenidate, amphetamines, modafinil, armodafinil, and pitolisant) the day before dosing and on each day when receiving a dose of solriamfetol.
9. Subjects must have sufficient blood volume for PK sampling based on body weight in accordance with applicable guidance (eg, European Commission’s recommendations document “Ethical considerations for clinical trials on medicinal products conducted with minors” 2017, or according to the IRB/EC guidelines).
10. Subjects must be willing and able to comply with the study schedule, all study procedures, and other requirements. |
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| E.4 | Principal exclusion criteria |
1.Subjects with any significant abnormality in the physical or psychological finding, or clinical laboratory results that could interfere with the study conduct or the ability of the subject to complete the study based on the judgement of the investigator, or place the subject at risk during the trial or compromise the study objectives.
2. Subjects with clinically significant disorders other than narcolepsy, including but not limited to, endocrine, neoplastic, gastrointestinal, hematological, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, renal disease, behavioral, or psychiatric disorder, which could interfere with the study conduct or the ability of the subject to complete the study based on the judgement of the investigator, or place the subject at risk during the study or compromise the study objectives.
3. Subjects with uncontrolled hypertension, uncontrolled cardiac arrhythmias, or systolic blood pressure and/or diastolic blood pressure values greater than the 95th percentile for sex, age, and height, any clinically significant electrocardiogram (ECG) abnormality in the opinion of the Investigator, or any history of cardiovascular disease or any significant cardiovascular condition that in the Investigator’s opinion may jeopardize a subject’s safety in the study.
4. Subjects with an estimated creatinine clearance (CrCL) < 90 mL/min.
5. Female subjects who are pregnant, nursing, or lactating.
6. Subjects with self-reported consumption of more than 200 mg of caffeine per day (for example, more than 12 oz [approximately 355 mL] of coffee).
7. Subjects with hemoglobin less than normal range for age and gender at Screening.
8. Subjects who are positive for urine drug screening for opiates, barbiturates, amphetamine, tetrahydrocannabinol (THC), benzodiazepines, or cocaine unless the subject is receiving prescribed drugs.
9. Subjects who are positive for the alcohol breath test.
10. Subjects who donated blood within 1 month before the start of the study.
11. Subjects who received any investigational drug within 30 days or 5 half-lives (whichever is longer) before Screening.
12. Subjects who are receiving monoamine oxidase inhibitors.
13. Subjects with allergy to any components of topical, local anesthetics that might be used for blood collection (not applicable if numbing agents will not be used).
14. Subjects with history or presence of phenylketonuria or hypersensitivity or idiosyncratic reaction to phenylalanine-derived products, or any excipient in the formulated drug products.
15. Subjects with current suicidal risk as determined from history, or Columbia Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Pharmacokinetics (PK) of JZP865 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Blood samples will be collected at pre-dose and at 1, 2, 3, 6, 8, and 10 hours after dosing for each Treatment Period (3 treatment periods per subject). |
|
| E.5.2 | Secondary end point(s) |
Incidence of treatment-emergent adverse events
Abnormal post-baseline results for vital signs, laboratory evaluations, 12-lead electrocardiograms, physical examinations, and C-SSRS evaluations
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Up until the end of the study |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | Yes |
| E.7.1.3.1 | Other trial type description |
| Pharmacokinetic and Safety |
|
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 12 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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