Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2011 |
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.
We found this trial at
1
site
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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