Narcolepsy Sleep disorder
Conditions
Interventions
On Day 1 you will be required to fast for 8 hours (no food and drinks, with the
exception of water). After this, you will be given a high calorie meal in the
evening. This meal must be consumed enti
Sponsors
Jazz Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects aged 18 to 45 years, inclusive. 2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, with a minimum body weight of 60 kg. 3. Good general health as determined by the investigator through medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory tests at Screening and baseline (Day -1). 4. Negative screens for human immunodeficiency virus antibodies (HIV-Ab), hepatitis B surface antigens (HBsAg), hepatitis C virus antibodies (HCV-Ab), hepatitis A IgM antibodies (Hep A IgM - Ab), and no clinical history related to these infections. 5. Negative urine drug and urine alcohol screens and negative serum pregnancy tests (for female subjects) at Screening and baseline (Day -1). (For the complete overview of the Main Inclusion Criteria see the protocol)
Exclusion criteria
Exclusion criteria: 1. Has a clinically significant unstable medical abnormality, chronic disease, or history or presence of significant neurological (including seizure and cognitive disorders) or psychiatric disorder (incl. depression suicidality, schizophrenia etc.), hepatic, renal, endocrine, cardiovascular (including hypertension), gastrointestinal, pulmonary, or metabolic disease or any other abnormality that could interfere with the pharmacokinetic evaluation of the study drug. 2. Has a history or the presence of gastrointestinal (including peptic ulcer), hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. 3. Is a female subject who is pregnant or plans to become pregnant during the study, nursing, or lactating. 4. Has any severe drug allergy or a history of allergic or severe adverse reactions (asthma, urticaria) or intolerance to oxybate products (eg. Xyrem), gamma-hydroxybutyrate (GHB), or any components of the dosage forms. 5. Has a history of substance (drug or alcohol) abuse within the last 2 years, known drug dependence, or positive test for drugs of abuse. (For the complete overview of the Main Inclusion Criteria see the protocol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of JZP-324 Formulation B following a single dose, in which the active moiety is equivalent to a 9g dose of sodium oxybate, at bedtime in healthy volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of JZP-324 Formulation B following a single dose, in which the active moiety is equivalent to a 9g dose of sodium oxybate, at bedtime in healthy volunteers. | — |
Countries
Netherlands
Outcome results
None listed