Narcolepsy MedDRA version: 21.1 Level: LLT Classification code 10021235 Term: Idiopathic narcolepsy System Organ Class: 100000004852
Conditions
Sponsors
Jazz Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 history of increased ocular pressure or at risk of angle closure glaucoma, or 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 > 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 < 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 (MAIOs), or who might receive MAOIs within 14 days prior to the first dose of solriamfetol. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy in improving wakefulness, and to characterize the pharmacokinetics (PK) of single doses of solriamfetol in pediatric subjects with narcolepsy. ;Secondary Objective: To assess the safety and tolerability of single doses of solriamfetol in pediatric subjects with narcolepsy. ;Primary end point(s): Efficacy - Change in Pictorial Sleepiness Scale (PSS) score from Day 1 predose to time of indivudual tmax postdose for each period. - Clinical Global Impression of change (CGIc) score on Day 1 relative to Day -1 for each period. Pharmacokinetics Pharmacokinetics parameters including, but not limited to, maximum plasma concentration (Cmax), time to reach Cmax (tmax), area under the plasma concentration-time curve from time 0 to the time t of the last quantifiable concentration (AUCO-t), area under the plasma concetration-time curve from time to infinity (AUCO-inf), apparent terminal elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent volume of distribution (Vd/F) at each solriamfetol dose in each age group.;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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy - Change in PSS score from Day 1 predose to 1, 2, 3, 4, 6, 8, and 10 hours postdose for each period. - Percentage of subjects with a CGIc of "much improved" or "minimally improved" on Day 1 relative to Day -1 for each period. Safety The occurrence of and/or change in: - AEs. - Vital Signs. - Physical examinations (including weight and height). - 12-lead electrocardiogram (ECG). - Clinical laboratory tests (chemistry, hematology, and urinalysis). - Columbia-Suicide Severity Rating Scale (C-SSRS) for emergent suicidality. - Serum and urine pregnancy tests (if applicable).;Timepoint(s) of evaluation of this end point: Up until the end of the study | — |
Countries
Belgium, France, Italy, Netherlands, Spain
Contacts
Public ContactMedicalMonitor for JZP865-101
Jazz Pharmaceuticals, Inc.
Outcome results
None listed