Calendario›XENE›XPF-008

XPF-008

Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.

Ensayo de Xenon Pharmaceuticals Inc. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

130

previstos

Centros

1

Fin del objetivo primario

nov 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, triple ciego. Comenzó en nov 2017.

Qué mide

Parts 1 & 2: Number of Participants with Adverse Events (AEs) (From screening (28 days prior to Day 1) through to 30 days post-final dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK data, the clinical trial has been designed to include a pharmacodynamic read-out by incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or electromyographic (EMG) activity. Part 3, 4 and 5: Phase 1, randomised, multi part study to evaluate the safety, tolerability, PK, relative bioavailability and food effect of single and multiple ascending doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment with Itraconazole.

Más ensayos de XENE

Todos los de XENE, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03340220), actualizada en may 2023.