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

Sponsor

UCB Biopharma S.P.R.L. (Industry)

Overall Status

Terminated

CT.gov ID

NCT04039919

Collaborator

(none)

Enrollment

Location

Arms

10.2

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Padsevonil Drug: Placebo (PSL)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jul 17, 2019

Actual Primary Completion Date :

May 22, 2020

Actual Study Completion Date :

May 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Padsevonil and Ethanol Subjects will be randomized to receive Padsevonil and Ethanol.	Drug: Padsevonil Padsevonil will be administered in predefined dosages.
Placebo Comparator: Part A: Padsevonil and Ethanol-Placebo Subjects will be randomized to receive Padsevonil and Ethanol-Placebo.	Drug: Padsevonil Padsevonil will be administered in predefined dosages.
No Intervention: Part A: Ethanol and Ethanol-Placebo Subjects will be randomized to receive Ethanol and Ethanol-Placebo.
No Intervention: Part A: Ethanol-Placebo and Ethanol Subjects will be randomized to receive Ethanol and Ethanol-Placebo.
Experimental: Part B: Padsevonil and Cannabidiol Subjects will be randomized to receive Padsevonil and Cannabidiol.	Drug: Padsevonil Padsevonil will be administered in predefined dosages.
Placebo Comparator: Part B: Padsevonil-Placebo and Cannabidiol Subjects will be randomized to receive Padsevonil-Placebo and Cannabidiol.	Drug: Placebo (PSL) Placebo will be provided matching Padsevonil to maintain the blinding.

Outcome Measures

Primary Outcome Measures

Percentage of Smooth Pursuit Eye Movements on Day 1 of Period 1 or Day 3 of Period 2 During Part A [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 [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 [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 [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 [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 [Predose up to 12 hours postdose]
AUCtau is the area under the curve over a dosing interval of CBD.

Secondary Outcome Measures

Breath Concentration of Ethanol Over Time on Day 1 of Period 1 or Day 3 of Period 2 During Part A [-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.
Breath Concentration of Ethanol Over Time on Day 5 of Period 4 or Day 7 of Period 5 During Part A [-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.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part A [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.
Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part A [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.
Half-life (t1/2) of Padsevonil During Part B [Predose up to 12 hours postdose]
t1/2 is the apparent terminal half-life of padsevonil.
Half-life (t1/2) of Cannabidiol During Part B [Predose up to 12 hours postdose]
t1/2 is the apparent terminal half-life of CBD.
Apparent Total Body Clearance at Steady State (CLss/F) of Padsevonil During Part B [Predose up to 12 hours postdose]
CLss/F is the apparent total body clearance at steady state following extravascular administration of padsevonil.
Apparent Total Body Clearance at Steady State (CLss/F) of Cannabidiol During Part B [Predose up to 12 hours postdose]
CLss/F is the apparent total body clearance at steady state following extravascular administration of CBD.
Percentage of Smooth Pursuit Eye Movements During Part B [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.
Saccadic Peak Velocity to Assess Sedation on Day 1 of Period 1 or Day 3 of Period 2 During Part A [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.
Saccadic Peak Velocity to Assess Sedation on Day 5 of Period 4 or Day 7 of Period 5 During Part A [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]
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.
Saccadic Peak Velocity to Assess Sedation During Part B [Treatment Period 1: Screening, Day 1 and Day 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.
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 1 of Period 1 or Day 3 of Period 2 During Part A [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 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.
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 5 of Period 4 or Day 7 of Period 5 During Part A [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]
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.
Adaptive Tracking to Assess Visuo-Motor Control and Vigilance During Part B [Treatment Period 1: Screening, Day 1 and Day 2]
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.
Body Sway to Assess Postural Stability on Day 1 of Period 1 or Day 3 of Period 2 During Part A [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 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.
Body Sway to Assess Postural Stability on Day 5 of Period 4 or Day 7 of Period 5 During Part A [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 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.
Body Sway to Assess Postural Stability During Part B [Treatment Period 1: Screening, Day 1 and Day 2]
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.
Number of Participants With Adverse Events During Part A [From Screening up to the Safety Follow-up visit of Part A (up to Day 26)]
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.
Number of Participants With Adverse Events During Part B [From Screening up to the Safety Follow-up visit of Part B (up to Day 66)]
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.
Number of Participants With Serious Adverse Events During Part A [From Screening up to the Safety Follow-up visit of Part A (up to Day 26)]
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.
Number of Participants With Serious Adverse Events During Part B [From Screening up to the Safety Follow-up visit of Part B (up to Day 66)]
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.
Number of Participants With Treatment-related Adverse Events During Part A [From Baseline up to Safety Follow-up visit of Part A (up to Day 26)]
Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.
Number of Participants With Treatment-related Adverse Events During Part B [From Baseline up to Safety Follow-up visit of Part B (up to Day 66)]
Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.
Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part A [From Screening up to Safety Follow-up visit of Part A (up to Day 26)]
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.
Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part B [From Screening up to Safety Follow-up visit of Part B (up to Day 66)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Up0071 001	Leiden		Netherlands

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators

Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

UCB Biopharma S.P.R.L.

ClinicalTrials.gov Identifier:

NCT04039919

Other Study ID Numbers:

UP0071
2019-000703-32

First Posted:

Jul 31, 2019

Last Update Posted:

Jun 18, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by UCB Biopharma S.P.R.L.

Ethanol

Cannabidiol

Padsevonil

Study Results

Participant Flow

Recruitment Details	The study started to enroll participants in July 2019 and concluded in May 2020.
Pre-assignment Detail	Participant Flow refers to the All Study Participants Set which included all participants who have signed the Informed Consent form (ICF).

Arm/Group Title	Part A: Treatment Sequence A	Part A: Treatment Sequence B	Part A: Treatment Sequence C	Part A: Treatment Sequence D	Part B: Cannabidiol (CBD)
Arm/Group Description	Participants received ethanol 0.6 grams per liter (g/L) intravenous (IV) infusion on Day 1 during Treatment Period 1 (TP1), followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then padsevonil (PSL) oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1, followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received a single oral dose of CBD 10 milligrams per kilogram (mg/kg) solution, under fasted condition on Day 1 during TP1.
Period Title: Treatment Period 1
STARTED	7	6	5	6	16
COMPLETED	6	6	5	6	0
NOT COMPLETED	1	0	0	0	16
Period Title: Treatment Period 1
STARTED	6	6	5	6	0
COMPLETED	6	6	5	6	0
NOT COMPLETED	0	0	0	0	0
Period Title: Treatment Period 1
STARTED	6	6	5	6	0
COMPLETED	6	6	5	6	0
NOT COMPLETED	0	0	0	0	0
Period Title: Treatment Period 1
STARTED	6	6	5	6	0
COMPLETED	6	6	5	6	0
NOT COMPLETED	0	0	0	0	0
Period Title: Treatment Period 1
STARTED	6	6	5	6	0
COMPLETED	5	6	5	6	0
NOT COMPLETED	1	0	0	0	0
Period Title: Treatment Period 1
STARTED	5	6	5	6	0
COMPLETED	5	6	5	6	0
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Part A: Treatment Sequence A	Part A: Treatment Sequence B	Part A: Treatment Sequence C	Part A: Treatment Sequence D	Part B: Cannabidiol (CBD)	Total Title
Arm/Group Description	Participants received ethanol 0.6 grams per liter (g/L) intravenous (IV) infusion on Day 1 during Treatment Period 1 (TP1), followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then padsevonil (PSL) oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1, followed by placebo (for ethanol IV infusion) on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received placebo (for ethanol IV infusion) on Day 1 during TP1, followed by ethanol 0.6 g/L IV infusion on Day 1 during TP2, then PSL oral tablets 100 mg or 200 mg BID on Day 1 to 4 during TP3, PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 5 during TP4, PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 7 during TP5, and then PSL 100 mg BID oral tablets on Day 9 during TP6. There was a washout of at least 2 days between Treatment Periods 2 and 3.	Participants received a single oral dose of CBD 10 milligrams per kilogram (mg/kg) solution, under fasted condition on Day 1 during TP1.
Overall Participants	7	6	5	6	16	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	6 100%	5 100%	6 100%	16 100%	40 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.3 (9.9)	30.8 (9.1)	28.4 (7.0)	30.7 (4.1)	27.9 (9.3)	29.2 (8.2)
Sex: Female, Male (Count of Participants)
Female	1 14.3%	4 66.7%	1 20%	1 16.7%	11 68.8%	18 45%
Male	6 85.7%	2 33.3%	4 80%	5 83.3%	5 31.3%	22 55%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	1 6.3%	1 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	7 100%	5 83.3%	5 100%	4 66.7%	15 93.8%	36 90%
Other or Mixed	0 0%	1 16.7%	0 0%	2 33.3%	0 0%	3 7.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Smooth Pursuit Eye Movements on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part A: Ethanol (FAS)	Part A: Placebo (FAS)
Arm/Group Description	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the FAS.	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Full Analysis Set (FAS).
Measure Participants	24	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)
8 hours	41.948 (10.245)	44.026 (10.085)
10 hours	43.491 (8.928)	43.504 (11.394)

2. Primary Outcome

Title	Percentage of Smooth Pursuit Eye Movements on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part A: PSL + Ethanol (FAS)	Part A: PSL + Placebo (FAS)
Arm/Group Description	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the FAS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the FAS.
Measure Participants	23	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)
8 hours	35.604 (8.894)	37.973 (8.849)
10 hours	38.570 (10.683)	38.591 (9.508)

3. Primary Outcome

Title	Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part B
Description	Cmax is maximum observed plasma concentration at steady state of padsevonil.
Time Frame	Predose up to 12 hours postdose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part B: PSL
Arm/Group Description	Zero participants received PSL during Part B because the study was terminated.
Measure Participants	0

4. Primary Outcome

Title	Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Cannabidiol During Part B
Description	Cmax is maximum observed plasma concentration at steady state of CBD.
Time Frame	Predose up to 12 hours postdose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part B: CBD (PKS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the PKS.
Measure Participants	16
Geometric Mean (95% Confidence Interval) [nanograms per milliliter]	NA

5. Primary Outcome

Title	Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part B
Description	AUCtau is the area under the curve over a dosing interval of padsevonil.
Time Frame	Predose up to 12 hours post dose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part B: PSL
Arm/Group Description	Zero participants received PSL during Part B because the study was terminated.
Measure Participants	0

6. Primary Outcome

Title	Area Under the Curve Over a Dosing Interval (AUCtau) of Cannabidiol During Part B
Description	AUCtau is the area under the curve over a dosing interval of CBD.
Time Frame	Predose up to 12 hours postdose

Outcome Measure Data

Analysis Population Description
PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

Arm/Group Title	Part B: CBD (PKS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the PKS.
Measure Participants	16
Geometric Mean (95% Confidence Interval) [hours*nanogram per milliliter]	NA

7. Secondary Outcome

Title	Breath Concentration of Ethanol Over Time on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

Arm/Group Title	Part A: Ethanol (PKS)
Arm/Group Description	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Pharmacokinetic Set (PKS).
Measure Participants	21
-0.4 hour	0.290
-0.3 hour	0.428
-0.2 hour	0.477
-0.16 hour	0.530
-0.08 hour	0.562
Predose	0.555
0.16 hour	0.578
0.3 hour	0.592
0.5 hour	0.574
1 hour	0.552
1.5 hours	0.557
2 hours	0.568
2.5 hours	0.574
3 hours	0.572
3.5 hours	0.574
4 hours	0.593
4.5 hours	0.603
5 hours	0.590
6 hours	0.356
7 hours	0.172
8 hours	0.105

8. Secondary Outcome

Title	Breath Concentration of Ethanol Over Time on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement. Here, n (number analyzed) signifies participants evaluable at specified time points only.

Arm/Group Title	Part A: PSL + Ethanol (PKS)
Arm/Group Description	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the PKS.
Measure Participants	21
-0.4 hour	0.321
-0.3 hour	0.464
-0.2 hour	0.499
-0.16 hour	0.524
-0.08 hour	0.505
Predose	0.499
0.16 hour	0.591
0.3 hour	0.622
0.5 hour	0.608
1 hour	0.581
1.5 hours	0.566
2 hours	0.566
2.5 hours	0.579
3 hours	0.608
3.5 hours	0.602
4 hours	0.612
4.5 hours	0.610
5 hours	0.613
6 hours	0.373
7 hours	0.199
8 hours	0.084

9. Secondary Outcome

Title	Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Padsevonil During Part A
Description	Cmax,ss is the maximum observed plasma concentration at steady state of padsevonil.
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

Outcome Measure Data

Analysis Population Description
PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement. Here, Number of participants analyzed signifies participants who were evaluable for the assessment.

Arm/Group Title	Part A: PSL + Ethanol (PKS)	Part A: PSL + Placebo (PKS)
Arm/Group Description	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the PKS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the PKS.
Measure Participants	20	21
Geometric Mean (95% Confidence Interval) [nanograms per milliliter]	832.9	1077

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Ethanol (FAS), Part A: Placebo (FAS)
	Comments	The log-transformed PK parameters was analyzed by a mixed analysis of variance (ANOVA) with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Geometric LS Mean ratio
	Estimated Value	0.7850
	Confidence Interval	(2-Sided) 90% 0.6513 to 0.9461
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Area Under the Curve Over a Dosing Interval (AUCtau) of Padsevonil During Part A
Description	AUC0-tau is the area under the curve over a dosing interval of padsevonil.
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

Outcome Measure Data

Analysis Population Description
PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement. Here, Number of participants analyzed signifies participants who were evaluable for the assessment.

Arm/Group Title	Part A: PSL + Ethanol (PKS)	Part A: PSL + Placebo (PKS)
Arm/Group Description	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the PKS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the PKS.
Measure Participants	20	20
Geometric Mean (95% Confidence Interval) [hours*nanogram per milliliter]	3504	4289

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Ethanol (FAS), Part A: Placebo (FAS)
	Comments	The log-transformed PK parameters was analyzed by a mixed ANOVA with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.
	Type of Statistical Test	Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Geometric LS Mean Ratio
	Estimated Value	0.8342
	Confidence Interval	(2-Sided) 90% 0.6999 to 0.9942
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Half-life (t1/2) of Padsevonil During Part B
Description	t1/2 is the apparent terminal half-life of padsevonil.
Time Frame	Predose up to 12 hours postdose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part B: PSL
Arm/Group Description	Zero participants received PSL during Part B because the study was terminated.
Measure Participants	0

12. Secondary Outcome

Title	Half-life (t1/2) of Cannabidiol During Part B
Description	t1/2 is the apparent terminal half-life of CBD.
Time Frame	Predose up to 12 hours postdose

Outcome Measure Data

Analysis Population Description
PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

Arm/Group Title	Part B: CBD (PKS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the PKS.
Measure Participants	16
Geometric Mean (95% Confidence Interval) [hours]	NA

13. Secondary Outcome

Title	Apparent Total Body Clearance at Steady State (CLss/F) of Padsevonil During Part B
Description	CLss/F is the apparent total body clearance at steady state following extravascular administration of padsevonil.
Time Frame	Predose up to 12 hours postdose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part B: PSL
Arm/Group Description	Zero participants received PSL during Part B because the study was terminated.
Measure Participants	0

14. Secondary Outcome

Title	Apparent Total Body Clearance at Steady State (CLss/F) of Cannabidiol During Part B
Description	CLss/F is the apparent total body clearance at steady state following extravascular administration of CBD.
Time Frame	Predose up to 12 hours postdose

Outcome Measure Data

Analysis Population Description
PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

Arm/Group Title	Part B: CBD (PKS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the PKS.
Measure Participants	16
Geometric Mean (95% Confidence Interval) [liter per hour]	NA

15. Secondary Outcome

Title	Percentage of Smooth Pursuit Eye Movements During Part B
Description	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.
Time Frame	Treatment Period 1: Screening, Day 1 and Day 2

Outcome Measure Data

Analysis Population Description
FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

Arm/Group Title	Part B: CBD (FAS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the FAS.
Measure Participants	16
Mean (Standard Deviation) [percentage of eye movements]	NA (NA)

16. Secondary Outcome

Title	Saccadic Peak Velocity to Assess Sedation on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part A: Ethanol (FAS)	Part A: Placebo (FAS)
Arm/Group Description	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the FAS.	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Full Analysis Set (FAS).
Measure Participants	24	23
Predose	497.873 (36.988)	502.917 (32.543)
0.5 hour	471.465 (37.890)	502.427 (47.354)
1 hour	458.726 (34.284)	488.761 (35.226)
2 hours	455.138 (34.045)	484.243 (37.299)
3 hours	455.445 (43.890)	479.852 (33.906)
4 hours	459.700 (54.621)	468.029 (36.669)
5 hours	447.909 (29.508)	484.778 (32.631)
6 hours	466.417 (37.985)	479.150 (37.994)
8 hours	474.283 (33.625)	486.883 (38.078)
10 hours	484.513 (33.232)	489.495 (38.495)

17. Secondary Outcome

Title	Saccadic Peak Velocity to Assess Sedation on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part A: PSL + Ethanol (FAS)	Part A: PSL + Placebo (FAS)
Arm/Group Description	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the FAS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the FAS.
Measure Participants	23	23
Predose	481.335 (40.894)	466.509 (43.334)
0.5 hour	434.465 (48.160)	454.980 (35.882)
1 hour	405.517 (50.706)	427.505 (42.232)
2 hours	414.268 (61.752)	418.748 (49.071)
3 hours	401.548 (46.004)	423.543 (51.720)
4 hours	410.386 (47.324)	442.152 (46.641)
5 hours	418.252 (41.277)	450.319 (38.954)
6 hours	436.268 (55.152)	470.576 (47.370)
8 hours	480.891 (41.106)	467.162 (37.902)
10 hours	474.209 (41.119)	466.933 (43.241)

18. Secondary Outcome

Title	Saccadic Peak Velocity to Assess Sedation During Part B
Description	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.
Time Frame	Treatment Period 1: Screening, Day 1 and Day 2

Outcome Measure Data

Analysis Population Description
FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

Arm/Group Title	Part B: CBD (FAS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the FAS.
Measure Participants	16
Mean (Standard Deviation) [degrees per second]	NA (NA)

19. Secondary Outcome

Title	Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part A: Ethanol (FAS)	Part A: Placebo (FAS)
Arm/Group Description	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the FAS.	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Full Analysis Set (FAS).
Measure Participants	24	23
Predose	32.3704 (5.5709)	32.0037 (5.6751)
0.5 hour	29.0825 (4.8924)	32.0770 (5.7220)
1 hour	28.7825 (5.0093)	32.0530 (5.6913)
2 hours	27.6325 (4.6875)	32.6526 (5.5194)
3 hours	26.5765 (5.9118)	32.3087 (6.0354)
4 hours	26.4087 (6.5784)	31.8835 (6.0274)
5 hours	27.9500 (5.1829)	32.0752 (5.8386)
6 hours	28.9587 (5.6291)	32.0757 (5.6722)
8 hours	31.0778 (5.7553)	32.0300 (5.8507)
10 hours	32.5391 (5.2327)	33.3322 (5.9769)

20. Secondary Outcome

Title	Adaptive Tracking to Assess Visuo-Motor Control and Vigilance on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part A: PSL + Ethanol (FAS)	Part A: PSL + Placebo (FAS)
Arm/Group Description	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the FAS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the FAS.
Measure Participants	23	22
Predose	30.5017 (7.0354)	29.0691 (7.1405)
0.5 hour	23.3339 (6.4727)	25.8650 (7.7624)
1 hour	19.4317 (7.5471)	20.5714 (7.7253)
2 hours	17.1617 (6.8895)	19.3395 (7.8659)
3 hours	18.4870 (6.9150)	25.0859 (7.2415)
4 hours	18.8713 (7.9952)	27.5827 (6.8106)
5 hours	20.4422 (8.3476)	29.4377 (6.5829)
6 hours	26.3652 (6.5759)	30.3214 (6.4549)
8 hours	30.3570 (6.3134)	31.3282 (5.9957)
10 hours	30.6039 (6.5557)	31.9223 (7.1749)

21. Secondary Outcome

Title	Adaptive Tracking to Assess Visuo-Motor Control and Vigilance During Part B
Description	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.
Time Frame	Treatment Period 1: Screening, Day 1 and Day 2

Outcome Measure Data

Analysis Population Description
FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

Arm/Group Title	Part B: CBD (FAS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the FAS.
Measure Participants	16
Mean (Standard Deviation) [percentage of time correctly tracked]	NA (NA)

22. Secondary Outcome

Title	Body Sway to Assess Postural Stability on Day 1 of Period 1 or Day 3 of Period 2 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Part A: Ethanol (FAS)	Part A: Placebo (FAS)
Arm/Group Description	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the FAS.	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Full Analysis Set (FAS).
Measure Participants	24	23
Predose	234.258 (131.198)	219.348 (123.362)
0.5 hour	390.671 (293.387)	238.083 (108.227)
1 hour	379.246 (226.889)	235.613 (115.707)
2 hours	410.292 (307.000)	258.348 (133.061)
3 hours	392.813 (300.259)	251.109 (141.894)
4 hours	410.500 (277.375)	241.361 (123.019)
5 hours	380.043 (238.041)	240.322 (131.546)
6 hours	298.445 (177.888)	285.191 (193.643)
8 hours	254.830 (134.773)	252.930 (166.126)
10 hours	244.057 (146.336)	239.283 (138.579)

23. Secondary Outcome

Title	Body Sway to Assess Postural Stability on Day 5 of Period 4 or Day 7 of Period 5 During Part A
Description	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.
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

Outcome Measure Data

Analysis Population Description
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 and n (number analyzed) signifies participants evaluable at specified time points only.

Arm/Group Title	Part A: PSL + Ethanol (FAS)	Part A: PSL + Placebo (FAS)
Arm/Group Description	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the FAS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the FAS.
Measure Participants	23	22
Predose	294.843 (227.524)	317.484 (321.623)
0.5 hour	746.161 (648.448)	661.550 (943.498)
1 hour	1091.639 (965.116)	863.255 (986.913)
2 hours	1170.452 (1118.424)	712.391 (646.223)
3 hours	924.800 (873.486)	499.077 (353.668)
4 hours	903.100 (888.205)	406.586 (279.517)
5 hours	666.987 (735.498)	353.905 (277.036)
6 hours	489.261 (431.766)	335.400 (256.120)
8 hours	314.713 (242.121)	277.614 (189.464)
10 hours	274.696 (180.248)	247.100 (137.795)

24. Secondary Outcome

Title	Body Sway to Assess Postural Stability During Part B
Description	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.
Time Frame	Treatment Period 1: Screening, Day 1 and Day 2

Outcome Measure Data

Analysis Population Description
FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

Arm/Group Title	Part B: CBD (FAS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the FAS.
Measure Participants	16
Mean (Standard Deviation) [millimeters]	NA (NA)

25. Secondary Outcome

Title	Number of Participants With Adverse Events During Part A
Description	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.
Time Frame	From Screening up to the Safety Follow-up visit of Part A (up to Day 26)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	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)
Arm/Group Description	Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part A. Participants formed SS.	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.	Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.
Measure Participants	24	23	24	23	23	23
Count of Participants [Participants]	8 114.3%	6 100%	17 340%	22 366.7%	22 137.5%	20 50%

26. Secondary Outcome

Title	Number of Participants With Adverse Events During Part B
Description	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.
Time Frame	From Screening up to the Safety Follow-up visit of Part B (up to Day 66)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	Part B: Pre-treatment (SS)	Part B: CBD (SS)
Arm/Group Description	Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part B. Participants formed SS.	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
Measure Participants	16	16
Count of Participants [Participants]	2 28.6%	11 183.3%

27. Secondary Outcome

Title	Number of Participants With Serious Adverse Events During Part A
Description	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.
Time Frame	From Screening up to the Safety Follow-up visit of Part A (up to Day 26)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	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)
Arm/Group Description	Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part A. Participants formed SS.	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.	Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.
Measure Participants	24	23	24	23	23	23
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

28. Secondary Outcome

Title	Number of Participants With Serious Adverse Events During Part B
Description	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.
Time Frame	From Screening up to the Safety Follow-up visit of Part B (up to Day 66)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	Part B: Pre-treatment (SS)	Part B: CBD (SS)
Arm/Group Description	Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part B. Participants formed SS.	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
Measure Participants	16	16
Count of Participants [Participants]	0 0%	0 0%

29. Secondary Outcome

Title	Number of Participants With Treatment-related Adverse Events During Part A
Description	Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.
Time Frame	From Baseline up to Safety Follow-up visit of Part A (up to Day 26)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	Part A: Placebo (SS)	Part A: Ethanol (SS)	Part A: PSL (SS)	Part A: PSL + Ethanol (SS)	Part A: PSL + Placebo (SS)
Arm/Group Description	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.	Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.
Measure Participants	23	24	23	23	23
Count of Participants [Participants]	1 14.3%	5 83.3%	21 420%	20 333.3%	18 112.5%

30. Secondary Outcome

Title	Number of Participants With Treatment-related Adverse Events During Part B
Description	Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.
Time Frame	From Baseline up to Safety Follow-up visit of Part B (up to Day 66)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	Part B: CBD (SS)
Arm/Group Description	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
Measure Participants	16
Count of Participants [Participants]	7 100%

31. Secondary Outcome

Title	Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part A
Description	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.
Time Frame	From Screening up to Safety Follow-up visit of Part A (up to Day 26)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	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)
Arm/Group Description	Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part A. Participants formed SS.	Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).	Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.	Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.	Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.	Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.
Measure Participants	24	23	24	23	23	23
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

32. Secondary Outcome

Title	Number of Participants With Adverse Events Leading to Discontinuation of the Study During Part B
Description	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.
Time Frame	From Screening up to Safety Follow-up visit of Part B (up to Day 66)

Outcome Measure Data

Analysis Population Description
Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Arm/Group Title	Part B: Pre-treatment (SS)	Part B: CBD (SS)
Arm/Group Description	Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part B. Participants formed SS.	Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
Measure Participants	16	16
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

	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)
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)
Adverse Event Reporting Description	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.

Arm/Group Title	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)
Arm/Group Description	Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part A. Participants formed SS.		Participants received matching placebo (for ethanol IV infusion) on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the Safety Set (SS).		Participants received ethanol 0.6 g/L IV infusion on Day 1 during TP1 in Treatment Sequence A and B and on Day 1 during TP2 in Treatment Sequence C and D. Participants formed the SS.		Participants received PSL 100 mg or 200 mg oral tablets BID on Day 1 to 4 during TP3 in Treatment Sequence A, B, C and D. Participants formed the SS.		Participants received PSL 200 mg BID oral tablets + Ethanol IV infusion on Day 5 during TP4 in Treatment Sequence A and C and on Day 7 during TP5 in Treatment Sequence B and D. Participants formed the SS.		Participants received PSL oral tablets 100 mg or 200 mg + Placebo (for ethanol IV infusion) on Day 7 during TP5 in Treatment Sequence A and C and on Day 5 during TP4 in Treatment Sequence B and D. Participants formed the SS.		Participants with adverse events with a start date prior to the first dose of treatment were summarized in this group for Part B. Participants formed SS.		Participants received a single oral dose of CBD 10 mg/kg solution, under fasted condition on Day 1 during TP1. Participants formed the SS.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/23 (0%)		0/24 (0%)		0/23 (0%)		0/23 (0%)		0/23 (0%)		0/16 (0%)		0/16 (0%)
Serious Adverse Events
	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)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/23 (0%)		0/24 (0%)		0/23 (0%)		0/23 (0%)		0/23 (0%)		0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	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)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/24 (16.7%)		4/23 (17.4%)		17/24 (70.8%)		22/23 (95.7%)		22/23 (95.7%)		18/23 (78.3%)		2/16 (12.5%)		11/16 (68.8%)
Gastrointestinal disorders
Diarrhoea	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	2/23 (8.7%)	2	0/23 (0%)	0	0/16 (0%)	0	2/16 (12.5%)	2
Nausea	0/24 (0%)	0	0/23 (0%)	0	2/24 (8.3%)	2	5/23 (21.7%)	6	8/23 (34.8%)	8	2/23 (8.7%)	3	0/16 (0%)	0	5/16 (31.3%)	5
Vomiting	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1	1/23 (4.3%)	1	2/23 (8.7%)	3	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
Flatulence	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
General disorders
Fatigue	2/24 (8.3%)	2	0/23 (0%)	0	2/24 (8.3%)	2	9/23 (39.1%)	11	3/23 (13%)	4	2/23 (8.7%)	2	0/16 (0%)	0	2/16 (12.5%)	2
Feeling Drunk	0/24 (0%)	0	0/23 (0%)	0	4/24 (16.7%)	4	1/23 (4.3%)	1	3/23 (13%)	3	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Infusion site bruising	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	2/23 (8.7%)	2	0/16 (0%)	0	0/16 (0%)	0
Infusion site pain	1/24 (4.2%)	1	1/23 (4.3%)	1	9/24 (37.5%)	9	0/23 (0%)	0	13/23 (56.5%)	13	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Catheter site inflammation	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
Malaise	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
Immune system disorders
Seasonal allergy	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
Infections and infestations
Urinary tract infection	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	2/23 (8.7%)	2	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Nasopharyngitis	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
Metabolism and nutrition disorders
Decreased appetite	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	3/23 (13%)	4	0/23 (0%)	0	1/23 (4.3%)	1	0/16 (0%)	0	0/16 (0%)	0
Musculoskeletal and connective tissue disorders
Pain in jaw	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
Nervous system disorders
Anterograde amnesia	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	5/23 (21.7%)	5	1/23 (4.3%)	1	1/23 (4.3%)	1	0/16 (0%)	0	0/16 (0%)	0
Ataxia	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	6/23 (26.1%)	7	2/23 (8.7%)	2	2/23 (8.7%)	2	0/16 (0%)	0	0/16 (0%)	0
Disturbance in attention	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	2/23 (8.7%)	2	0/23 (0%)	0	1/23 (4.3%)	1	0/16 (0%)	0	0/16 (0%)	0
Dizziness	0/24 (0%)	0	1/23 (4.3%)	1	6/24 (25%)	7	17/23 (73.9%)	30	7/23 (30.4%)	7	1/23 (4.3%)	1	0/16 (0%)	0	2/16 (12.5%)	2
Head discomfort	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	2/23 (8.7%)	2	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Headache	1/24 (4.2%)	1	0/23 (0%)	0	5/24 (20.8%)	5	7/23 (30.4%)	13	7/23 (30.4%)	10	1/23 (4.3%)	1	2/16 (12.5%)	2	3/16 (18.8%)	3
Slow response to stimuli	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	3/23 (13%)	3	1/23 (4.3%)	1	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Somnolence	0/24 (0%)	0	3/23 (13%)	3	3/24 (12.5%)	3	20/23 (87%)	43	15/23 (65.2%)	23	14/23 (60.9%)	26	0/16 (0%)	0	0/16 (0%)	0
Speech disorder	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	2/23 (8.7%)	2	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Sudden onset of sleep	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	15/23 (65.2%)	33	6/23 (26.1%)	9	3/23 (13%)	3	0/16 (0%)	0	0/16 (0%)	0
Tremor	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	4/23 (17.4%)	4	0/23 (0%)	0	1/23 (4.3%)	1	0/16 (0%)	0	0/16 (0%)	0
Psychiatric disorders
Agitation	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	5/23 (21.7%)	5	0/23 (0%)	0	3/23 (13%)	3	0/16 (0%)	0	0/16 (0%)	0
Anxiety	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	3/23 (13%)	4	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Bradyphrenia	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	2/23 (8.7%)	2	1/23 (4.3%)	1	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Depressed mood	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	2/23 (8.7%)	3	0/23 (0%)	0	2/23 (8.7%)	2	0/16 (0%)	0	0/16 (0%)	0
Illusion	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	3/23 (13%)	4	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Insomnia	0/24 (0%)	0	0/23 (0%)	0	1/24 (4.2%)	1	5/23 (21.7%)	5	2/23 (8.7%)	2	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Negative thoughts	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	0/23 (0%)	0	2/23 (8.7%)	2	0/16 (0%)	0	0/16 (0%)	0
Nightmare	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	2/23 (8.7%)	2	1/23 (4.3%)	1	0/16 (0%)	0	0/16 (0%)	0
Panic attack	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	3/23 (13%)	3	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Paranoia	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	2/23 (8.7%)	2	0/23 (0%)	0	0/16 (0%)	0	0/16 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hiccups	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	3/23 (13%)	5	1/23 (4.3%)	1	1/23 (4.3%)	1	0/16 (0%)	0	0/16 (0%)	0
Yawning	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1
Skin and subcutaneous tissue disorders
Erythema	0/24 (0%)	0	0/23 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/16 (0%)	0	1/16 (6.3%)	1

Limitations/Caveats

The study was terminated because the decision was made to terminate the PSL development program in focal-onset seizures on 22 May 2020.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	UCB
Organization	Cares
Phone	+1844 599 ext 2273
Email	UCBCares@ucb.com

Responsible Party:

UCB Biopharma S.P.R.L.

ClinicalTrials.gov Identifier:

NCT04039919

Other Study ID Numbers:

UP0071
2019-000703-32

First Posted:

Jul 31, 2019

Last Update Posted:

Jun 18, 2021

Last Verified:

May 1, 2021

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

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact