drugset / Trial / NCT02390258
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
RandomizedSingle-groupQuadruple-blindTreatment
Summary
This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.
Timeline
- Start
- 2011-07
- Primary completion
- 2011-12
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XEN-D0103 | Unknown | 10 mg | — |
| Subject | XEN-D0103 | Unknown | 30 mg | — |
| Subject | XEN-D0103 | Unknown | 60 mg | — |
| Subject | XEN-D0103 | Unknown | 120 mg | — |
| Subject | XEN-D0103 | Unknown | 150 mg | — |
| Subject | XEN-D0103 | Unknown | 200 mg | — |