NCT04126343

A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants

A Single-Center, Randomized, Placebo-Controlled, 3 Treatment Period Crossover Study to Assess the Effect of Padsevonil on Cardiac Repolarization (QTc Interval) (Using Moxifloxacin as a Positive Control) in Healthy Study Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the effects on cardiac repolarization of high-dose padsevonil (PSL) in comparison to placebo in healthy study participants.

Conditions

• Healthy Study Participants

Interventions

Type	Name	Description
DRUG	Padsevonil	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use * Study participants will receive padsevonil in a pre-specified dosing sequence during the Treatment Period
DRUG	Moxifloxacin	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use * Study participants will receive moxifloxacin once during the Treatment Period
DRUG	Placebo	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use * Study participants will receive placebo in a pre-specified sequence during the Treatment Period to match padsevonil and maintain the blinding

Timeline

• Start date: 2019-10-23
• Primary completion: 2020-05-22
• Completion: 2020-05-22
• First posted: 2019-10-15
• Last updated: 2021-06-18
• Results posted: 2021-06-18

Locations

1 site across 1 country: United Kingdom