An open label, randomized, 4 treatments, 4 periods, 4 sequence crossover study to assess the pharmacokinetics of four 6 g single-doses of once-nightly sodium oxybate (FT218) formulations with varying release rates in healthy volunteers

Completed

Conditions: Narcolepsy
10040998

Registration Number: NL-OMON48344

Lead Sponsor: Flamel Ireland Ltd doing business as Avadel Ireland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess bioequivalence of pharmacokinetic parameters Cmax, AUC0-t, and<br /><br>AUC0-inf for sodium oxybate in plasma</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical and laboratory safety and tolerability. Safety will be evaluated based<br /><br>on reported adverse events, physical examinations, pulse oximetry, vital signs,<br /><br>ECG, and safety laboratory test results.</p><br>