Trials / Terminated
TerminatedNCT04039919
A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol
A Double-Blind, Placebo-Controlled, Randomized, Single-Center, Cross-Over Study to Investigate the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Padsevonil | Padsevonil will be administered in predefined dosages. |
| DRUG | Placebo (PSL) | Placebo will be provided matching Padsevonil to maintain the blinding. |
Timeline
- Start date
- 2019-07-17
- Primary completion
- 2020-05-22
- Completion
- 2020-05-22
- First posted
- 2019-07-31
- Last updated
- 2021-06-18
- Results posted
- 2021-06-18
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04039919. Inclusion in this directory is not an endorsement.