NCT04039919 is a Phase 1 clinical trial of Padsevonil in Healthy Participants, sponsored by UCB Biopharma S.P.R.L..

Who is sponsoring NCT04039919?

NCT04039919 is sponsored by UCB Biopharma S.P.R.L..

What drugs are being tested in NCT04039919?

Interventions in NCT04039919: Padsevonil, Placebo (PSL).

What condition does NCT04039919 study?

NCT04039919 studies Healthy Participants.

Is NCT04039919 still recruiting?

NCT04039919 is currently terminated. Last updated 18 June 2021.

Are results published for NCT04039919?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-18 · How we verify

NCT04039919

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Results posted Last updated 18 June 2021

What this trial tests

Phase 1 trial testing Padsevonil in Healthy Participants in 40 participants. Terminated before completion.

Timeline

17 July 2019

Primary endpoint
22 May 2020

22 May 2020

Quick facts

Lead sponsor	UCB Biopharma S.P.R.L.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	40
Start date	17 July 2019
Primary completion	22 May 2020
Estimated completion	22 May 2020
Sites	1 location across Netherlands

Drugs / interventions tested

Padsevonil — full drug profile →
Placebo (PSL) — full drug profile →

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

UCB Biopharma S.P.R.L. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Smooth Pursuit Eye Movements on Day 1 of Period 1 or Day 3 of Period 2 During Part A Primary · Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 10 hours postdose on Day 1 of Period 1 or Day 3 of Period 2

Smooth pursuit to assess eye movement coordination and attention to evaluate the ethanol effect. The average percentage of smooth pursuit for all stimulus frequencies was used as a parameter. Participants received either ethanol or placebo on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

Predose

Group	Value	95% CI
Part A: Ethanol (FAS)	44.838	± 9.110
Part A: Placebo (FAS)	43.252	± 8.688

0.5 hour

Group	Value	95% CI
Part A: Ethanol (FAS)	38.046	± 8.674
Part A: Placebo (FAS)	43.661	± 9.345

1 hour

Group	Value	95% CI
Part A: Ethanol (FAS)	37.604	± 8.574
Part A: Placebo (FAS)	43.748	± 10.298

2 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	37.300	± 8.778
Part A: Placebo (FAS)	42.930	± 9.636

3 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	36.726	± 7.441
Part A: Placebo (FAS)	42.809	± 10.639

4 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	36.822	± 8.405
Part A: Placebo (FAS)	42.478	± 9.351

5 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	35.913	± 7.359
Part A: Placebo (FAS)	42.622	± 9.200

6 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	40.570	± 9.353
Part A: Placebo (FAS)	43.300	± 8.960

Percentage of Smooth Pursuit Eye Movements on Day 5 of Period 4 or Day 7 of Period 5 During Part A Primary · Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 10 hours postdose on Day 5 of Period 4 or Day 7 of Period 5

Smooth pursuit to assess eye movement coordination and attention to evaluate the ethanol effect. The average percentage of smooth pursuit for all stimulus frequencies was used as a parameter. Participants received either ethanol or placebo on Day 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.

Predose

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	41.107	± 9.930
Part A: PSL + Placebo (FAS)	41.402	± 8.500

0.5 hour

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	32.591	± 7.140
Part A: PSL + Placebo (FAS)	39.655	± 9.703

1 hour

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	30.874	± 6.790
Part A: PSL + Placebo (FAS)	35.814	± 7.893

2 hours

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	28.309	± 5.321
Part A: PSL + Placebo (FAS)	36.036	± 9.172

3 hours

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	28.530	± 6.881
Part A: PSL + Placebo (FAS)	36.727	± 9.512

4 hours

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	30.400	± 9.466
Part A: PSL + Placebo (FAS)	36.668	± 8.411

5 hours

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	30.239	± 6.750
Part A: PSL + Placebo (FAS)	35.714	± 8.865

6 hours

Group	Value	95% CI
Part A: PSL + Ethanol (FAS)	33.761	± 8.383
Part A: PSL + Placebo (FAS)	38.945	± 9.676

Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Cannabidiol During Part B Primary · Predose up to 12 hours postdose

Cmax is maximum observed plasma concentration at steady state of CBD.

Group	Value	95% CI
Part B: CBD (PKS)	NA	NA – NA

Area Under the Curve Over a Dosing Interval (AUCtau) of Cannabidiol During Part B Primary · Predose up to 12 hours postdose

AUCtau is the area under the curve over a dosing interval of CBD.

Group	Value	95% CI
Part B: CBD (PKS)	NA	NA – NA

Breath Concentration of Ethanol Over Time on Day 1 of Period 1 or Day 3 of Period 2 During Part A Secondary · -0.4, -0.3, -0.2, -0.16, -0.08, Predose, 0.16, 0.3, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7 and 8 hours postdose on Day 1 of Period 1 or on Day 3 of Period 2

Continuous infusion of ethanol began with a 30 minute loading phase (prior to 0 hours) and was continued for 5 hours with adjustments during the infusion. Participants received either ethanol on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

-0.4 hour

Group	Value	95% CI
Part A: Ethanol (PKS)	0.290	0.254 – 0.333

-0.3 hour

Group	Value	95% CI
Part A: Ethanol (PKS)	0.428	0.379 – 0.483

-0.2 hour

Group	Value	95% CI
Part A: Ethanol (PKS)	0.477	0.446 – 0.511

-0.16 hour

Group	Value	95% CI
Part A: Ethanol (PKS)	0.530	0.499 – 0.564

-0.08 hour

Group	Value	95% CI
Part A: Ethanol (PKS)	0.562	0.539 – 0.585

Predose

Group	Value	95% CI
Part A: Ethanol (PKS)	0.555	0.538 – 0.571

0.16 hour

Group	Value	95% CI
Part A: Ethanol (PKS)	0.578	0.558 – 0.599

0.3 hour

Group	Value	95% CI
Part A: Ethanol (PKS)	0.592	0.574 – 0.611

Breath Concentration of Ethanol Over Time on Day 5 of Period 4 or Day 7 of Period 5 During Part A Secondary · -0.4, -0.3, -0.2, -0.16, -0.08, Predose, 0.16, 0.3, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7 and 8 hours postdose on Day 5 of Period 4 or Day 7 of Period 5

Continuous infusion of ethanol began with a 30 minute loading phase (prior to 0 hours) and was continued for 5 hours with adjustments during the infusion. Participants received either ethanol on Day 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.

-0.4 hour

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.321	0.281 – 0.367

-0.3 hour

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.464	0.417 – 0.516

-0.2 hour

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.499	0.451 – 0.553

-0.16 hour

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.524	0.492 – 0.558

-0.08 hour

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.505	0.468 – 0.545

Predose

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.499	0.467 – 0.533

0.16 hour

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.591	0.567 – 0.617

0.3 hour

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	0.622	0.606 – 0.639

Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part A Secondary · Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose on Day 5

Cmax,ss is the maximum observed plasma concentration at steady state of padsevonil.

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	832.9	488.3 – 1421
Part A: PSL + Placebo (PKS)	1077	778.6 – 1489

Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part A Secondary · Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose on Day 5

AUC0-tau is the area under the curve over a dosing interval of padsevonil.

Group	Value	95% CI
Part A: PSL + Ethanol (PKS)	3504	2010 – 6109
Part A: PSL + Placebo (PKS)	4289	2904 – 6335

Half-life (t1/2) of Cannabidiol During Part B Secondary · Predose up to 12 hours postdose

t1/2 is the apparent terminal half-life of CBD.

Group	Value	95% CI
Part B: CBD (PKS)	NA	NA – NA

Apparent Total Body Clearance at Steady State (CLss/F) of Cannabidiol During Part B Secondary · Predose up to 12 hours postdose

CLss/F is the apparent total body clearance at steady state following extravascular administration of CBD.

Group	Value	95% CI
Part B: CBD (PKS)	NA	NA – NA

Percentage of Smooth Pursuit Eye Movements During Part B Secondary · Treatment Period 1: Screening, Day 1 and Day 2

Smooth pursuit to assess eye movement coordination and attention to evaluate the ethanol effect. The average percentage of smooth pursuit for all stimulus frequencies was used as a parameter.

Group	Value	95% CI
Part B: CBD (FAS)	NA	± NA

Saccadic Peak Velocity to Assess Sedation on Day 1 of Period 1 or Day 3 of Period 2 During Part A Secondary · Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 10 hours postdose on Day 1 of Period 1 or Day 3 of Period 2

Sixteen saccades were recorded with interstimulus intervals varying randomly. Average values of latency (reaction time), saccadic peak velocity of all correct saccades, and inaccuracy of all saccades were used as parameters. Participants received either ethanol or placebo on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

Predose

Group	Value	95% CI
Part A: Ethanol (FAS)	497.873	± 36.988
Part A: Placebo (FAS)	502.917	± 32.543

0.5 hour

Group	Value	95% CI
Part A: Ethanol (FAS)	471.465	± 37.890
Part A: Placebo (FAS)	502.427	± 47.354

1 hour

Group	Value	95% CI
Part A: Ethanol (FAS)	458.726	± 34.284
Part A: Placebo (FAS)	488.761	± 35.226

2 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	455.138	± 34.045
Part A: Placebo (FAS)	484.243	± 37.299

3 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	455.445	± 43.890
Part A: Placebo (FAS)	479.852	± 33.906

4 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	459.700	± 54.621
Part A: Placebo (FAS)	468.029	± 36.669

5 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	447.909	± 29.508
Part A: Placebo (FAS)	484.778	± 32.631

6 hours

Group	Value	95% CI
Part A: Ethanol (FAS)	466.417	± 37.985
Part A: Placebo (FAS)	479.150	± 37.994

Adverse events — posted to ClinicalTrials.gov

Time frame: From Screening up to Safety Follow-up visit of Part A (up to Day 26) and of Part B (up to Day 66). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Pre-treatment (SS)

Serious: 0/24 (0%)

Deaths: 0/24

Part A: Placebo (SS)

Serious: 0/23 (0%)

Deaths: 0/23

Part A: Ethanol (SS)

Serious: 0/24 (0%)

Deaths: 0/24

Part A: PSL (SS)

Serious: 0/23 (0%)

Deaths: 0/23

Part A: PSL + Ethanol (SS)

Serious: 0/23 (0%)

Deaths: 0/23

Part A: PSL + Placebo (SS)

Serious: 0/23 (0%)

Deaths: 0/23

Part B: Pre-treatment (SS)

Serious: 0/16 (0%)

Deaths: 0/16

Part B: CBD (SS)

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (39 terms — click to expand)

Reaction	System	Part A: Pre-treatment (SS)	Part A: Placebo (SS)	Part A: Ethanol (SS)	Part A: PSL (SS)	Part A: PSL + Ethanol (SS)	Part A: PSL + Placebo (SS)	Part B: Pre-treatment (SS)	Part B: CBD (SS)
Somnolence	Nervous system disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Sudden onset of sleep	Nervous system disorders	—	—	—	—	—	—	—	—
Infusion site pain	General disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Ataxia	Nervous system disorders	—	—	—	—	—	—	—	—
Anterograde amnesia	Nervous system disorders	—	—	—	—	—	—	—	—
Agitation	Psychiatric disorders	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—
Feeling Drunk	General disorders	—	—	—	—	—	—	—	—
Tremor	Nervous system disorders	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Slow response to stimuli	Nervous system disorders	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—
Illusion	Psychiatric disorders	—	—	—	—	—	—	—	—
Panic attack	Psychiatric disorders	—	—	—	—	—	—	—	—
Hiccups	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Infusion site bruising	General disorders	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Disturbance in attention	Nervous system disorders	—	—	—	—	—	—	—	—
Head discomfort	Nervous system disorders	—	—	—	—	—	—	—	—
Speech disorder	Nervous system disorders	—	—	—	—	—	—	—	—
Bradyphrenia	Psychiatric disorders	—	—	—	—	—	—	—	—
Depressed mood	Psychiatric disorders	—	—	—	—	—	—	—	—
Negative thoughts	Psychiatric disorders	—	—	—	—	—	—	—	—
Nightmare	Psychiatric disorders	—	—	—	—	—	—	—	—
Paranoia	Psychiatric disorders	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Catheter site inflammation	General disorders	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Pain in jaw	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Yawning	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04039919 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Padsevonil

Trials testing the same drug.

NCT04136444 — A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function · Phase 1 · terminated
NCT04131517 — A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants · Phase 1 · terminated
NCT04126343 — A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants · Phase 1 · terminated
NCT04075409 — A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants · Phase 1 · completed
NCT04013191 — A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Partic · Phase 1 · completed

Other recruiting trials for Healthy Participants

Currently open trials in the same condition.

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Other UCB Biopharma S.P.R.L. trials

Trials by the same sponsor.

NCT04136444 — A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function · Phase 1 · terminated
NCT04126343 — A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants · Phase 1 · terminated
NCT04075409 — A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants · Phase 1 · completed
NCT04013191 — A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Partic · Phase 1 · completed
NCT04875962 — A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients Wit · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04039919 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma S.P.R.L.
Last refreshed: 18 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04039919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04039919

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Padsevonil

Other recruiting trials for Healthy Participants

Other UCB Biopharma S.P.R.L. trials

Verify against primary sources