drugset / Trial / NCT02693197
PK Study of T-817 in Subjects With Hepatic Impairment
Non-randomizedParallel-groupOpen-labelBasic science
Summary
The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects. The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | T-817MA | Unknown | 448 mg | Oral |
Indications
No indication recorded.