Hepatic Impairment Clinical Trial
Official title:
An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon With That in Matched Healthy Control Subjects
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver function.
The study will employ an open-label, parallel-group design. Up to 32 subjects will be enrolled in 3 groups: Group 1 will consist of 8 subjects with mild hepatic impairment; Group 2 will consist of 8 subjects with moderate hepatic impairment; Group 3 will consist of up to 16 healthy subjects matched by gender, age, smoking status, and body mass index, to Groups 1 and/or 2. For each group, there will be a 21-day screening period, a baseline period, a single-dose treatment period with an on-site observation period of 36 hours, and a study completion evaluation conducted after the last PK blood sample is drawn. Each subject will receive a single 20-mg dose of tasimelteon, after which safety assessments will be performed. ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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