Healthy ParticipantsPhase 1NCT04039919

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

A Phase 1 study testing Padsevonil in people with Healthy Participants, run by UCB Biopharma S.P.R.L. at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Padsevonil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteNetherlands
Study dates: 17 Jul 2019to 22 May 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Participant must have previous experience with alcohol consumption and, therefore, must be familiar with the effects and able to tolerate social amounts of alcohol
Participant has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)
Participants are male or female:
A male participant must agree to use contraception as detailed in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period

Show all 9Show fewer

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Not a woman of childbearing potential (WOCBP) as defined n the protocol OR
A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 90 days after the last dose of study treatment

Who cannot join

Participant has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
Participant has a history of chronic alcohol or drug abuse within the previous 6 months or the presence of drug or alcohol dependency at Screening or Day -1 or tests positive for alcohol and/or drugs at Screening or Day -1
Participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
Participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
Participant has lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Participant has past or intended use of over-the-counter or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing

Show all 13Show fewer

Participant has used hepatic enzyme-inducing drugs within 2 months prior to dosing
Participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)
Participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline
Participant has the presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to dosing
Participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention
Participant has a positive human immunodeficiency virus (HIV) antibody test

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Up0071 001
Leiden

Other trials in Netherlands

About this study

Official title: 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

Conditions: Healthy Participants
Being tested: Padsevonil, Placebo (PSL)
Keywords: Ethanol, Cannabidiol, Padsevonil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PadsevonilDrug
Padsevonil will be administered in predefined dosages.
Placebo (PSL)Drug
Placebo will be provided matching Padsevonil to maintain the blinding.

Study groups in NCT04039919
Study group	Role	What they receive
Part A: Padsevonil and Ethanol	Experimental	Subjects will be randomized to receive Padsevonil and Ethanol. Receives: Drug: Padsevonil
Part A: Padsevonil and Ethanol-Placebo	Placebo comparator	Subjects will be randomized to receive Padsevonil and Ethanol-Placebo. Receives: Drug: Padsevonil
Part A: Ethanol and Ethanol-Placebo	No intervention	Subjects will be randomized to receive Ethanol and Ethanol-Placebo.
Part A: Ethanol-Placebo and Ethanol	No intervention	Subjects will be randomized to receive Ethanol and Ethanol-Placebo.
Part B: Padsevonil and Cannabidiol	Experimental	Subjects will be randomized to receive Padsevonil and Cannabidiol. Receives: Drug: Padsevonil
Part B: Padsevonil-Placebo and Cannabidiol	Placebo comparator	Subjects will be randomized to receive Padsevonil-Placebo and Cannabidiol. Receives: Drug: Placebo (PSL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Smooth Pursuit Eye Movements on Day 1 of Period 1 or Day 3 of Period 2 During Part A
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.
Measured: 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
Percentage of Smooth Pursuit Eye Movements on Day 5 of Period 4 or Day 7 of Period 5 During Part A
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.
Measured: 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
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part B
Cmax is maximum observed plasma concentration at steady state of padsevonil.
Measured: Predose up to 12 hours postdose
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Cannabidiol During Part B
Cmax is maximum observed plasma concentration at steady state of CBD.
Measured: Predose up to 12 hours postdose
Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part B
AUCtau is the area under the curve over a dosing interval of padsevonil.
Measured: Predose up to 12 hours post dose
Area Under the Curve Over a Dosing Interval (AUCtau) of Cannabidiol During Part B
AUCtau is the area under the curve over a dosing interval of CBD.
Measured: Predose up to 12 hours postdose

Secondary outcomes (26)

Breath Concentration of Ethanol Over Time on Day 1 of Period 1 or Day 3 of Period 2 During Part A
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.
Measured: -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
Breath Concentration of Ethanol Over Time on Day 5 of Period 4 or Day 7 of Period 5 During Part A
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.
Measured: -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
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part A
Cmax,ss is the maximum observed plasma concentration at steady state of padsevonil.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose on Day 5
Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part A
AUC0-tau is the area under the curve over a dosing interval of padsevonil.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose on Day 5
Half-life (t1/2) of Padsevonil During Part B
t1/2 is the apparent terminal half-life of padsevonil.
Measured: Predose up to 12 hours postdose
Half-life (t1/2) of Cannabidiol During Part B
t1/2 is the apparent terminal half-life of CBD.
Measured: Predose up to 12 hours postdose
Apparent Total Body Clearance at Steady State (CLss/F) of Padsevonil During Part B
CLss/F is the apparent total body clearance at steady state following extravascular administration of padsevonil.
Measured: Predose up to 12 hours postdose
Apparent Total Body Clearance at Steady State (CLss/F) of Cannabidiol During Part B
CLss/F is the apparent total body clearance at steady state following extravascular administration of CBD.
Measured: Predose up to 12 hours postdose
Percentage of Smooth Pursuit Eye Movements During Part B
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.
Measured: Treatment Period 1: Screening, Day 1 and Day 2
Saccadic Peak Velocity to Assess Sedation on Day 1 of Period 1 or Day 3 of Period 2 During Part A
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.
Measured: 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
Saccadic Peak Velocity to Assess Sedation on Day 5 of Period 4 or Day 7 of Period 5 During Part A
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 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.
Measured: 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
Saccadic Peak Velocity to Assess Sedation During Part B
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.
Measured: Treatment Period 1: Screening, Day 1 and Day 2
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 1 of Period 1 or Day 3 of Period 2 During Part A
The adaptive tracking test was performed as originally described by Borland and Nicholson (Borland and Nicholson, 1984). Performance was scored after a fixed period of 3.5 minutes and reflected visuo-motor control and vigilance. The average performance scores were used in the analysis. 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.
Measured: 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
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 5 of Period 4 or Day 7 of Period 5 During Part A
The adaptive tracking test was performed as originally described by Borland and Nicholson (Borland and Nicholson, 1984). Performance was scored after a fixed period of 3.5 minutes and reflected visuo-motor control and vigilance. The average performance scores were used in the analysis. 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.
Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 10 hours on Day 5 of Period 4 or Day 7 of Period 5
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance During Part B
The adaptive tracking test was performed as originally described by Borland and Nicholson (Borland and Nicholson, 1984). Performance was scored after a fixed period of 3.5 minutes and reflected visuo-motor control and vigilance.
Measured: Treatment Period 1: Screening, Day 1 and Day 2
Body Sway to Assess Postural Stability on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Body Sway test measured the study participant's body movements in a single direction. Body sway was measured by CHCR NeuroCart. Study participants were asked to stand erect and motionless with their eyes closed. The amplitude and direction of any Body Sway was recorded for 1 minute. 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.
Measured: 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
Body Sway to Assess Postural Stability on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Body Sway test measured the study participant's body movements in a single direction. Body sway was measured by CHCR NeuroCart. Study participants were asked to stand erect and motionless with their eyes closed. The amplitude and direction of any Body Sway was recorded for 1 minute. 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.
Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 10 hours on Day 5 of Period 4 or Day 7 of Period 5
Body Sway to Assess Postural Stability During Part B
Body Sway test measured the study participant's body movements in a single direction. Body sway was measured by CHCR NeuroCart. Study participants were asked to stand erect and motionless with their eyes closed. The amplitude and direction of any Body Sway was recorded for 1 minute.
Measured: Treatment Period 1: Screening, Day 1 and Day 2
Number of Participants With Adverse Events During Part A
An adverse event (AE) was any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Measured: From Screening up to the Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Adverse Events During Part B
An AE was any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Measured: From Screening up to the Safety Follow-up visit of Part B (up to Day 66)
Number of Participants With Serious Adverse Events During Part A
A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.
Measured: From Screening up to the Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Serious Adverse Events During Part B
A SAE was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.
Measured: From Screening up to the Safety Follow-up visit of Part B (up to Day 66)
Number of Participants With Treatment-related Adverse Events During Part A
Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.
Measured: From Baseline up to Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Treatment-related Adverse Events During Part B
Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.
Measured: From Baseline up to Safety Follow-up visit of Part B (up to Day 66)
Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part A
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Screening up to Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part B
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Screening up to Safety Follow-up visit of Part B (up to Day 66)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 201922 May 2020

First posted31 Jul 2019
Study start17 Jul 2019
Primary completion22 May 2020
Study completion22 May 2020

Why it stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04039919
Sponsor's protocol ID: UP0071
Other IDs: 2019-000703-32, 2019
Status last verified: May 2021
First submitted: 12 Jul 2019
Last updated: 18 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants

All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04039919
Acronym / sponsor ID: UP0071
Conditions: Healthy Participants
Keywords: Ethanol, Cannabidiol, Padsevonil
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Enrolment: 40 participants (actual)
Lead sponsor: UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
Study start: 17 Jul 2019 (actual)
Primary completion: 22 May 2020 (actual)
Study completion: 22 May 2020 (actual)
First posted: 31 Jul 2019 (actual)
Results: Posted 18 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Part A: Padsevonil and Ethanol	Experimental	Drug: PadsevonilSubjects will be randomized to receive Padsevonil and Ethanol.
Part A: Padsevonil and Ethanol-Placebo	Placebo comparator	Drug: PadsevonilSubjects will be randomized to receive Padsevonil and Ethanol-Placebo.
Part A: Ethanol and Ethanol-Placebo	No intervention	–Subjects will be randomized to receive Ethanol and Ethanol-Placebo.
Part A: Ethanol-Placebo and Ethanol	No intervention	–Subjects will be randomized to receive Ethanol and Ethanol-Placebo.
Part B: Padsevonil and Cannabidiol	Experimental	Drug: PadsevonilSubjects will be randomized to receive Padsevonil and Cannabidiol.
Part B: Padsevonil-Placebo and Cannabidiol	Placebo comparator	Drug: Placebo (PSL)Subjects will be randomized to receive Padsevonil-Placebo and Cannabidiol.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Participant must have previous experience with alcohol consumption and, therefore, must be familiar with the effects and able to tolerate social amounts of alcohol
Participant has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)
Participants are male or female:

Key exclusion criteria (13 listed)

Participant has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
Participant has a history of chronic alcohol or drug abuse within the previous 6 months or the presence of drug or alcohol dependency at Screening or Day -1 or tests positive for alcohol and/or drugs at Screening or Day -1
Participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
Participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
Participant has lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PadsevonilPadsevonil will be administered in predefined dosages.	Drug	Part A: Padsevonil and Ethanol, Part A: Padsevonil and Ethanol-Placebo, Part B: Padsevonil and Cannabidiol
Placebo (PSL)Placebo will be provided matching Padsevonil to maintain the blinding.	Drug	Part B: Padsevonil-Placebo and Cannabidiol

Primary outcome

Percentage of Smooth Pursuit Eye Movements on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Time frame: 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.
Percentage of Smooth Pursuit Eye Movements on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Time frame: 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.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part B
Time frame: Predose up to 12 hours postdose
Cmax is maximum observed plasma concentration at steady state of padsevonil.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Cannabidiol During Part B
Time frame: Predose up to 12 hours postdose
Cmax is maximum observed plasma concentration at steady state of CBD.
Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part B
Time frame: Predose up to 12 hours post dose
AUCtau is the area under the curve over a dosing interval of padsevonil.
Area Under the Curve Over a Dosing Interval (AUCtau) of Cannabidiol During Part B
Time frame: Predose up to 12 hours postdose
AUCtau is the area under the curve over a dosing interval of CBD.

26 secondary outcomes

Breath Concentration of Ethanol Over Time on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Time frame: -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
Breath Concentration of Ethanol Over Time on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Time frame: -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
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part A
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose on Day 5
Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part A
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose on Day 5
Half-life (t1/2) of Padsevonil During Part B
Time frame: Predose up to 12 hours postdose
Half-life (t1/2) of Cannabidiol During Part B
Time frame: Predose up to 12 hours postdose
Apparent Total Body Clearance at Steady State (CLss/F) of Padsevonil During Part B
Time frame: Predose up to 12 hours postdose
Apparent Total Body Clearance at Steady State (CLss/F) of Cannabidiol During Part B
Time frame: Predose up to 12 hours postdose
Percentage of Smooth Pursuit Eye Movements During Part B
Time frame: Treatment Period 1: Screening, Day 1 and Day 2
Saccadic Peak Velocity to Assess Sedation on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Time frame: 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
Saccadic Peak Velocity to Assess Sedation on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Time frame: 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
Saccadic Peak Velocity to Assess Sedation During Part B
Time frame: Treatment Period 1: Screening, Day 1 and Day 2
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Time frame: 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
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 10 hours on Day 5 of Period 4 or Day 7 of Period 5
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance During Part B
Time frame: Treatment Period 1: Screening, Day 1 and Day 2
Body Sway to Assess Postural Stability on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Time frame: 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
Body Sway to Assess Postural Stability on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 10 hours on Day 5 of Period 4 or Day 7 of Period 5
Body Sway to Assess Postural Stability During Part B
Time frame: Treatment Period 1: Screening, Day 1 and Day 2
Number of Participants With Adverse Events During Part A
Time frame: From Screening up to the Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Adverse Events During Part B
Time frame: From Screening up to the Safety Follow-up visit of Part B (up to Day 66)
Number of Participants With Serious Adverse Events During Part A
Time frame: From Screening up to the Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Serious Adverse Events During Part B
Time frame: From Screening up to the Safety Follow-up visit of Part B (up to Day 66)
Number of Participants With Treatment-related Adverse Events During Part A
Time frame: From Baseline up to Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Treatment-related Adverse Events During Part B
Time frame: From Baseline up to Safety Follow-up visit of Part B (up to Day 66)
Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part A
Time frame: From Screening up to Safety Follow-up visit of Part A (up to Day 26)
Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part B
Time frame: From Screening up to Safety Follow-up visit of Part B (up to Day 66)

Results and safety

Results posted to the registry on 18 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Treatment Sequence A	7	6
Part A: Treatment Sequence B	6	6
Part A: Treatment Sequence C	5	5
Part A: Treatment Sequence D	6	6
Part B: Cannabidiol (CBD)	16	0

Primary outcome: Percentage of Smooth Pursuit Eye Movements on Day 1 of Period 1 or Day 3 of Period 2 During Part A

Time frame: 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. Mean (Standard Deviation). Unit: percentage of eye movements

Measure	Part A: Ethanol (FAS) n = 24	Part A: Placebo (FAS) n = 23
Predose	44.838 (9.110)	43.252 (8.688)
0.5 hour	38.046 (8.674)	43.661 (9.345)
1 hour	37.604 (8.574)	43.748 (10.298)
2 hours	37.300 (8.778)	42.930 (9.636)
3 hours	36.726 (7.441)	42.809 (10.639)
4 hours	36.822 (8.405)	42.478 (9.351)
5 hours	35.913 (7.359)	42.622 (9.200)
6 hours	40.570 (9.353)	43.300 (8.960)

Population analysed: Full Analysis Set (FAS) consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, n (number analyzed) signifies participants evaluable at specified time points only.

Primary outcome: Percentage of Smooth Pursuit Eye Movements on Day 5 of Period 4 or Day 7 of Period 5 During Part A

Time frame: 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. Mean (Standard Deviation). Unit: percentage of eye movements

Measure	Part A: PSL + Ethanol (FAS) n = 23	Part A: PSL + Placebo (FAS) n = 22
Predose	41.107 (9.930)	41.402 (8.500)
0.5 hour	32.591 (7.140)	39.655 (9.703)
1 hour	30.874 (6.790)	35.814 (7.893)
2 hours	28.309 (5.321)	36.036 (9.172)
3 hours	28.530 (6.881)	36.727 (9.512)
4 hours	30.400 (9.466)	36.668 (8.411)
5 hours	30.239 (6.750)	35.714 (8.865)
6 hours	33.761 (8.383)	38.945 (9.676)

Population analysed: FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, Number of participants analyzed signifies participants who were evaluable for the assessment.

Primary outcome: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part B

Time frame: Predose up to 12 hours postdose

Population analysed: Analysis of this outcome measure was not performed because the study was terminated. At that time, Part A had been completed, and 16 study participants had been treated with CBD in Treatment Period 1 of Part B.

Primary outcome: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Cannabidiol During Part B

Time frame: Predose up to 12 hours postdose. Geometric mean (95% Confidence Interval). Unit: nanograms per milliliter

Measure	Part B: CBD (PKS) n = 16
Value	NA (NA to NA)

Population analysed: Pharmacokinetic Set (PKS) included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

26 secondary outcomes are reported in the full results.

Adverse events

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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Pre-treatment (SS)	0 of 24 (0%)	4 of 24 (16.7%)	0 of 24
Part A: Placebo (SS)	0 of 23 (0%)	4 of 23 (17.4%)	0 of 23
Part A: Ethanol (SS)	0 of 24 (0%)	17 of 24 (70.8%)	0 of 24
Part A: PSL (SS)	0 of 23 (0%)	22 of 23 (95.7%)	0 of 23
Part A: PSL + Ethanol (SS)	0 of 23 (0%)	22 of 23 (95.7%)	0 of 23
Part A: PSL + Placebo (SS)	0 of 23 (0%)	18 of 23 (78.3%)	0 of 23
Part B: Pre-treatment (SS)	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
Part B: CBD (SS)	0 of 16 (0%)	11 of 16 (68.8%)	0 of 16

Limitations and caveats (from the sponsor): The study was terminated because the decision was made to terminate the PSL development program in focal-onset seizures on 22 May 2020.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Related trials for Healthy Participants

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Cares study director

001 844 599 2273 (UCB)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Padsevonil in people with Healthy Participants, run by UCB Biopharma S.P.R.L. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Smooth Pursuit Eye Movements on Day 1 of Period 1 or Day 3 of Period 2 During Part A (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04039919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.