An open-label, sequential study to assess the drug-drug interaction of divalproex sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6-G evening dose in healthy male volunteers.

Completed

Conditions: Cataplexy
Narcolepsy
10040998

Registration Number: NL-OMON48371

Lead Sponsor: Flamel Ireland Limited (Ltd) trading under the business name Avadel Ireland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the PK of a single 6-g evening dose of FT218 with or without 1250<br /><br>mg/day divalproex sodium ER at steady-state in healthy male volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety of a single evening dose of 6 g FT218 with or without 1250<br /><br>mg/day divalproex sodium ER at steady-state in healthy male volunteers.</p><br>