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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2020-05-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function

NCT04136444

Healthy Study Participants Impaired Hepatic Function

TERMINATED PHASE1

A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures

NCT00105040

Epilepsy, Partial

COMPLETED PHASE2

Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus

NCT00362141

Status Epilepticus

UNKNOWN PHASE2

Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

NCT00152503

Epilepsy, Partial

COMPLETED PHASE2

Effect of Levetiracetam on Brain Excitability

NCT00006191

Healthy Myoclonic Epilepsy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: Padsevonil and Ethanol

Subjects will be randomized to receive Padsevonil and Ethanol.

Group Type EXPERIMENTAL

Padsevonil

Intervention Type DRUG

Padsevonil will be administered in predefined dosages.

Part A: Padsevonil and Ethanol-Placebo

Subjects will be randomized to receive Padsevonil and Ethanol-Placebo.

Group Type PLACEBO_COMPARATOR

Padsevonil

Intervention Type DRUG

Padsevonil will be administered in predefined dosages.

Part A: Ethanol and Ethanol-Placebo

Subjects will be randomized to receive Ethanol and Ethanol-Placebo.

Group Type NO_INTERVENTION

No interventions assigned to this group

Part A: Ethanol-Placebo and Ethanol

Subjects will be randomized to receive Ethanol and Ethanol-Placebo.

Group Type NO_INTERVENTION

No interventions assigned to this group

Part B: Padsevonil and Cannabidiol

Subjects will be randomized to receive Padsevonil and Cannabidiol.

Group Type EXPERIMENTAL

Padsevonil

Intervention Type DRUG

Padsevonil will be administered in predefined dosages.

Part B: Padsevonil-Placebo and Cannabidiol

Subjects will be randomized to receive Padsevonil-Placebo and Cannabidiol.

Group Type PLACEBO_COMPARATOR

Placebo (PSL)

Intervention Type DRUG

Placebo will be provided matching Padsevonil to maintain the blinding.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Padsevonil

Padsevonil will be administered in predefined dosages.

Intervention Type DRUG

Placebo (PSL)

Placebo will be provided matching Padsevonil to maintain the blinding.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes