A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Bedtime Dosing of JZP-324 (Extended Release Oxybate) for Oral Suspension in Healthy Subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the pharmacokinetics of JZP-324 Formulation B following a single<br /><br>dose, in which the active moiety is equivalent to a 9g dose of sodium oxybate,<br /><br>at bedtime in healthy volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of JZP-324 Formulation B following a<br /><br>single dose, in which the active moiety is equivalent to a 9g dose of sodium<br /><br>oxybate, at bedtime in healthy volunteers.</p><br>