Trials / Completed
CompletedNCT02390258
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Xention Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 10mg XEN-D0103 | |
| DRUG | Placebo | |
| DRUG | 30mg XEN-D0103 | |
| DRUG | 60mg XEN-D0103 | |
| DRUG | 120mg XEN-D0103 | |
| DRUG | 200mg XEN-D0103 | |
| DRUG | 150mg XEN-D0103 |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2015-03-17
- Last updated
- 2015-03-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02390258. Inclusion in this directory is not an endorsement.