The purpose of this study is to investigate how quickly and to what extent 4 different formulations of FT218 are absorbed, distributed, metabolized and eliminated from the body.It will also be investigated how safe FT218 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 assess bioequivalence of pharmacokinetic parameters Cmax, AUC0-t, and
AUC0-inf for sodium oxybate in plasma
Secondary outcome
Clinical and laboratory safety and tolerability. Safety will be evaluated based
on reported adverse events, physical examinations, pulse oximetry, vital signs,
ECG, and safety laboratory test results.
Background summary
FT218 is a new compound that may eventually be used for the treatment of
narcolepsy. For some people with narcolepsy, it also involves a sudden loss of
muscle tone (cataplexy), usually triggered by strong emotion. FT218 is a new
formulation of the drug sodium oxybate/GHB, a substance that has depressant or
sedating effects in people.
Sodium oxybate is a registered drug under the tradename Xyrem®. Xyrem® is an
oral solution that has to be taken at bedtime, and then again 2.5 to 4 hours
later. This dosing schedule is considered inconvenient for the patients because
they have to wake up in the middle of the night to take the second dose. FT218
contains the same active substance (sodium oxybate) as Xyrem®, but in a special
formulation which provides slower and longer release of the active substance.
As a result, FT218 only has to be taken once at bedtime. FT218 is in
development and is not registered as a drug, but it has been given to over 300
humans before.
FT218 is made of the active ingredient sodium oxybate encapsulated in very
small particles made of naturally occurring substances (polymers). The Sponsor
has conducted research and studies to show that the particles used can be
broken down by the human body and that the components are not harmful. These
particles have been used previously in humans without any safety concern.
Study objective
The purpose of this study is to investigate how quickly and to what extent 4
different formulations of FT218 are absorbed, distributed, metabolized and
eliminated from the body.
It will also be investigated how safe FT218 is and how well it is tolerated.
Study design
The actual study will consist of 4 periods during each of which the volunteer
will stay in the research center for 2 days (1 night). In each treatment
period, Day 1 is the day of administration of the study compound. In each
treatment period, the volunteer is expected at the research center at 10:00 h
in the morning of Day 1. In each treatment period, the volunteer will leave the
research center on Day 2.
The study consists of 4 treatment periods. In each treatment period, the
volunteer will receive a single dose of 6 gram of FT218 as an oral drink of 50
milliliters. After each administration of the study compound, the dosing cup
will be rinsed once with 20 mL of water, which the volunteer will also be
required to drink.
There are 4 different types of the FT218 drink: Types A, B, C and D. These 4
drinks all contain 6 g of FT218 but differ slightly in their composition.
Intervention
The study consists of 4 treatment periods. In each treatment period, the
volunteer will receive a single dose of 6 gram of FT218 as an oral drink of 50
milliliters. After each administration of the study compound, the dosing cup
will be rinsed once with 20 mL of water, which the volunteer will also be
required to drink.
There are 4 different types of the FT218 drink: Types A, B, C and D. These 4
drinks all contain 6 g of FT218 but differ slightly in their composition.
Study burden and risks
In previous studies, FT218 was investigated in 172 healthy volunteers as single
doses of 4.5 g, 6 g, and 7.5 g. The following is a list of side effects that
were reported during these studies:
Very common (>10% of volunteers): nausea, sleepiness, dizziness, headache
Common (5-10% of volunteers): Feeling drunk, vomiting, somnolence, tiredness,
abdominal discomfort, lightheaded feeling, drowsiness.
Uncommon (1-5% of volunteers): vertigo, pain and/or bruising at site of blood
draw, fatigue, muscle relaxation, ataxia, feeling warm, insomnia, loose stool,
neck and/or leg myalgia, increased sweating, decreased appetite, blurred
vision, abnormal dreams, paresthesia, relaxed feeling, disturbed sleep, dyspnea
(shortness of breath), numbness, common cold, dry mouth, feeling high, malaise,
sedation, feeling worried
The active substance in FT218 (sodium oxybate) is the same as the active
substance in Xyrem®, a registered drug. The risks associated with FT218 are
expected to be similar to those associated with Xyrem®. As FT218 is a new
once-nightly formulation of sodium oxybate, there may be some side effects that
are not yet known. The following is a list of the known potential side effects
of sodium oxybate:
The most commonly reported adverse reactions are dizziness, nausea, and
headache, all occurring in 10% to 20% of patients.
Less common side effects (in 1% to 10% of patients) are nasopharyngitis,
sinusitis, anorexia, decreased appetite, depression, cataplexy, anxiety,
abnormal dreams, confused state, disorientation, nightmares, sleepwalking,
sleep disorder, insomnia, insomnia in the middle of the night, nervousness,
sleep paralysis, somnolence, tremor, balance disorder, disturbance in
attention, hypoesthesia, paresthesia, sedation, dysgeusia, blurred vision,
vertigo, palpitations, hypertension, dyspnea, snoring, nasal congestion,
vomiting, diarrhea, upper abdominal pain, hyperhidrosis (increased sweating),
rash, arthralgia, muscle spasms, back pain, enuresis nocturna, urinary
incontinence, asthenia, fatigue, feeling drunk, edema peripheral, increased
blood pressure, decreased weight, and risk of a fall.
Uncommon side effects (in 0.1% to 1% of patients) are hypersensitivity, suicide
attempt, psychosis, paranoia, hallucination, abnormal thinking, agitation,
initial insomnia, myoclonus, amnesia, restless leg syndrome, and fecal
incontinence.
The most serious (but uncommon) adverse reactions are suicidal attempt,
psychosis, respiratory depression and convulsion.
Block 10-1, Ballycoolin Unit 1
Dublin 15
IE
Block 10-1, Ballycoolin Unit 1
Dublin 15
IE
Listed location countries
Age
Inclusion criteria
1. Gender: male or female; females may be of childbearing potential, of
non-childbearing
potential, or postmenopausal.
2. Age: 18-65 years, inclusive, at screening
3. BMI: 18.0-30.0 kg/m2, inclusive, at screening
4. Weight: >=60 kg
5. Status: healthy, as determined by the Investigator. Determination will be
based on full medical evaluation including past medical history, physical
examination, vital signs,laboratory tests, and ECG.
Exclusion criteria
1. The presence of any unstable or clinically significant medical or
psychiatric disorders (asdetermined by medical or psychiatric history, physical
examination, and/or clinical laboratory test) which in the opinion of the
Investigator may either put the subject at risk by participation in the study
or may influence the results of the study
2. History of seizures
3. Any finding in the medical history, physical examination, or clinical
laboratory tests giving reasonable suspicion of a disease that would
contraindicate taking FT218, or a known poor tolerability to the active compound
4. Subjects with a previous history or current ideation of suicide attempt
5. Subjects with a medical diagnosis of Major Depression, as defined by the
DSM-IV Criteria for Major Depression Disorder, which in the opinion of the
Investigator would impact subject safety and place the subject at risk by
participation in the study
Design
Recruitment
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 | EUCTR2019-004009-28-NL |
| CCMO | NL72100.056.19 |