AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-TREATMENT (FED VS FASTING), TWO-PERIOD, TWO-SEQUENCE CROSSOVER STUDY TO ASSESS THE EFFECT OF FOOD ON SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUPENSION (FT218) FORMULATION ADMINISTRERED AT 6 G IN HEALTHY VOLUNTEERS

FT218 is a new compound that may eventually be used for the treatment of
narcolepsy. Narcolepsy is a sleeping disorder that involves excessive daytime
sleepiness. For some people with narcolepsy it also involves a sudden loss of
muscle tone (cataplexy), usually triggered by strong emotion.

Sodium oxybate/GHB is a substance that has depressant or sedating effects in
people. 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 molecule or 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 humans before.

FT218 is made of the active ingredient sodium oxybate encapsulated in very
small particles made of naturally occurring substances (polymers). Avadel has
conducted all research and studies needed 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.

FT218 is a new formulation (composition) of the registered drug sodium oxybate.
Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid
[GHB]) is registered under the name Xyrem® for the treatment of narcolepsy
(excessive sleepiness). FT218 has been given to humans before.

The purpose of this study is to investigate how food affects how quickly and to
what extent FT218 is absorbed and eliminated from the body (this is called
pharmacokinetics) when given in a single dose of 6 gram. It will also be
investigated how safe the new compound FT218 is when it is administered to
fasted and fed healthy subjects as a single dose of 6 grams.

The actual study will consist of 2 periods during which the volunteer will stay
in the research center in Groningen Martini Hospital for 3 days (2 nights).

Day 1 is the first day of administration of the study compound. They are
expected at the research center at 14:00 h in the morning prior to the day of
first administration of the study compound (Day 1). They will leave the
research center on Day 2 of the study.

Not applicable.

Pain, minor bleedings, bruises, possibly an infection.