The purpose of this study is to investigate how quickly and to what extend JZP-324 is absorbed and eliminated from the body (this is called pharmacokinetics). It will also be investigated how safe the new compound JZP-324 is and how well it is…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
JZP-324 is a new formulation and composition of oxybates that is being
evaluated for the treatment of narcolepsy. Narcolepsy is a sleeping disorder
that involves excessive daytime sleepiness and, in some people, sudden loss of
muscle tone usually triggered by strong emotions (cataplexy). One of the
current medications for narcolepsy is Xyrem® (sodium oxybate, also known as the
sodium salt of gamma-hydroxybutyric acid [GHB]). Xyrem slows down the activity
of the central nervous system and therefore has a depressant or sedative effect
on people. Volunteer should be aware that it comes with a warning label as
breathing difficulties can occur with Xyrem use. Xyrem is a solution that has
to be taken twice nightly. JZP-324 is an investigational, extended release
formulation that is expected to provide the same therapeutic benefits when
taken once a night. In addition, Xyrem contains a high sodium (salt) content
and JZP-324 has a reduced amount of sodium.
Study objective
The purpose of this study is to investigate how quickly and to what extend
JZP-324 is absorbed and eliminated from the body (this is called
pharmacokinetics). It will also be investigated how safe the new compound
JZP-324 is and how well it is tolerated when it is administered to healthy
volunteers. JZP-324 has been administered to humans before in a previous
clinical trial. The active compound in JZP-324 has also been extensively tested
in the laboratory and on animals. JZP-324 will be tested at a fixed dose of 9
grams and will be given at bedtime, 2 hours after eating a high-fat meal.
This study will be performed in approximately 16 healthy male and female
volunteers.
Study design
The actual study will consist of 1 period during which the volunteer will stay
in the research center for 4 days (3 nights).
The volunteer will be tested for the presence of coronavirus upon admission to
the research center. Until the test results are available, the volunteer will
be separated from other volunteers and only have very limited contact with
study staff. This is to avoid virus spread from potentially infected volunteers
to other volunteers or to the study staff because, until the results are
available, it is not certain whether the volunteer is infected or not and can
thus potentially infect others. The test results will be available within one
hour. If the volunteer test positive for coronavirus, volunteer cannot
participate in the study.
The coronavirus test will be done on the following days:
• Day -1 (upon admission)
• Day 2
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 entirely within 30 minutes.
Two hours after the start of the meal the volunteer will receive 9 grams of
JZP-324 as a single dose. JZP-324 will be given as granules in an oral
suspension of 50 milliliters (mL) of (tap) water. After administration of the
study compound, the dosing cup will be rinsed twice with 60 mL of water, which
the volunteer will also be required to drink.
After receiving JZP-324, the volunteer must fast again for 8 hours. However, 1
hour after dosing the volunteer may drink water.
During the first 4 hours after administration of the study compound the
volunteer must stay in bed (except when indicated as such by one of the
investigators). When the 4 hours have passed, the volunteer will be determined
for his / her degree of alertness and coordination before he / she can get out
of bed again.
Intervention
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 entirely within 30 minutes.
Two hours after the start of the meal the volunteer will receive 9 grams of
JZP-324 as a single dose. JZP-324 will be given as granules in an oral
suspension of 50 milliliters (mL) of (tap) water. After administration of the
study compound, the dosing cup will be rinsed twice with 60 mL of water, which
The volunteer will also be required to drink.
After receiving JZP-324, you must fast again for 8 hours. However, 1 hour after
dosing you may drink water.
During the first 4 hours after administration of the study compound The
volunteer must stay in bed (except when indicated as such by one of the
investigators). When the 4 hours have passed, the volunteer will be determined
for his / her degree of alertness and coordination before he / she can get out
of bed again.
Study burden and risks
The active substance in JZP-324 is the same as the active substance in Xyrem
(sodium oxybate). The risks associated with JZP-324 are expected to be similar
to those associated with Xyrem.
The safety of JZP-324 has been investigated in a single clinical trial before.
This study found that JZP-324 is safe, was well tolerated and lead to similar
side effects as Xyrem. The most side effects were of mild severity, and none
were severe.
The most commonly reported side effects of JZP-324 (in more than 10% of the
volunteers) were:
• Sleepiness
• Dizziness
• Headache
• Myoclonus (quick, involuntary muscle jerk)
• Fatigue
• Feeling hot
• Nausea
• Vomiting
• Euphoric mood
• Decreased appetite
Possible discomforts due to procedures:
Drawing blood and/or insertion of the indwelling cannula (tube in an arm vein)
may be painful or cause some bruising.
To make a heart tracing, electrodes (small, plastic patches) will be pasted at
specific locations on arms, chest and legs. Prolonged use of these electrodes
can cause skin irritation (rash and itching).
A sample for the coronavirus test will be taken from the back of the nose and
throat using a swab. Taking the sample only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
the throat may cause volunteer to gag. When the sample is taken from the back
of the nose, volunteer may experience a stinging sensation and the eyes may
become watery.
3170 Porter Drive na
Palo Alto CA 94304
US
3170 Porter Drive na
Palo Alto CA 94304
US
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-000124-19-NL |
| CCMO | NL73098.056.20 |