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

UCB

Status and phase: Terminated; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo (PSL); Drug: Padsevonil

Study type: Interventional

Funder types: Industry

Identifiers

NCT04039919

2019-000703-32 (EudraCT Number)

UP0071

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

40 participants in 6 patient groups, including a placebo group

Part A: Padsevonil and Ethanol

Experimental group

Description:

Subjects will be randomized to receive Padsevonil and Ethanol.

Treatment:

Drug: Padsevonil

Part A: Padsevonil and Ethanol-Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Padsevonil

Part A: Ethanol and Ethanol-Placebo

No Intervention group

Description:

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

Part A: Ethanol-Placebo and Ethanol

No Intervention group

Description:

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

Part B: Padsevonil and Cannabidiol

Experimental group

Description:

Subjects will be randomized to receive Padsevonil and Cannabidiol.

Treatment:

Drug: Padsevonil

Part B: Padsevonil-Placebo and Cannabidiol

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (PSL)