Status:
TERMINATED
A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol
Lead Sponsor:
UCB Biopharma S.P.R.L.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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-st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04039919
Start Date
July 17 2019
End Date
May 22 2020
Last Update
June 18 2021
Active Locations (1)
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1
Up0071 001
Leiden, Netherlands