Narcolepsy
Conditions
Interventions
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
Sponsors
Flamel Ireland Ltd doing business as Avadel Ireland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess bioequivalence of pharmacokinetic parameters Cmax, AUC0-t, and AUC0-inf for sodium oxybate in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed