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A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol

NCT04039919 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-18

Study results available
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Summary

The purpose of the study is to evaluate the pharmacodynamic (PD) interaction between steady-steady treatment with padsevonil (PSL) and Ethanol and the pharmacokinetic (PK) interaction between stead-state treatment with PSL and cannabidiol (CBD).

Conditions

  • Healthy Participants

Interventions

DRUG

Padsevonil

Padsevonil will be administered in predefined dosages.

DRUG

Placebo (PSL)

Placebo will be provided matching Padsevonil to 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
2019-07-17
Primary Completion
2020-05-22
Completion
2020-05-22

Countries

  • Netherlands

Study Locations

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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 NCT04039919 on ClinicalTrials.gov