drugset / Trial / NCT02390258

Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103

NCT02390258 ↗

Phase 1 Completed 87 enrolled Xention Ltd
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

EvaluationDrugModalityDoseRoute
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 —

Indications