A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Japanese Participants

Treatments: Drug: Padsevonil

Study type: Interventional

Funder types: Industry

Identifiers

NCT04075409

JapicCTI-194958 (Registry Identifier)

UP0083

Details and patient eligibility

About

The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.

Enrollment: 39 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The study participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent
• The study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• The study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage
• The study participant has a body weight ≥50 kg and body mass index within the range [18 to 30] kg/m^2 (inclusive)
• The study participant is male

Exclusion criteria

• The study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study, such as a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at the Screening Visit
• The study participant has a 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
• The study participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
• The study participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
• The study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0 x upper limit of normal (ULN)
• The study participant has bilirubin >1.0 x ULN (isolated bilirubin >1.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %)
• The study participant has current or chronic history of liver disease or known hepatic or biliary abnormalities
• The study participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline.
• The study participant has made a blood or plasma donation or has had a comparable blood loss (>450 mL) within the last 30 days prior to Screening. Blood donation during the study is not permitted

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Extensive metabolizers

Experimental group

Description:

Participants will receive assigned single and multiple doses of padsevonil.

Treatment:

Drug: Padsevonil

Intermediate metabolizers

Experimental group

Description:

Participants will receive assigned single and multiple doses of padsevonil.

Treatment:

Drug: Padsevonil

Poor metabolizers

Experimental group

Description:

Participants will receive assigned single and multiple doses of padsevonil.

Treatment:

Drug: Padsevonil