Cataplexy Narcolepsy
Conditions
Interventions
During the study the subjects will receive 6 gram (g) of FT218 as an oral drink
(a suspension) of 50 milliliters (mL). After administration of the study
compound, the dosing cup will be rinsed once
Sponsors
Flamel Ireland Limited (Ltd) trading under the business name Avadel Ireland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male 2. Age: 18-55 years, inclusive, at screening 3. BMI: 18.0-28.0 kg/m2, 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. Employee of PRA or the Sponsor 2. The presence of any unstable or clinically significant medical or psychiatric disorders (as determined by medical or psychiatric history, physical examination, and/or clinical laboratory tests) 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 3. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, pancreatic, renal, metabolic, hematological, neurologic, systemic, or infectious disease 4. Any family history of severe drug-related hepatic dysfunction 5. History of seizure, head trauma, or past-intracranial surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PK of a single 6-g evening dose of FT218 with or without 1250 mg/day divalproex sodium ER at steady-state in healthy male volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of a single evening dose of 6 g FT218 with or without 1250 mg/day divalproex sodium ER at steady-state in healthy male volunteers. | — |
Countries
Netherlands
Outcome results
None listed