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

NCT04126343 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-06-18

Study results available
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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

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

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2020-05-22
Completion
2020-05-22

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04126343 on ClinicalTrials.gov