Clinical trial NCT04075409: A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
Official title: An Open-Label, Parallel Group, Single-Center Study to Investigate the Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in CYP2C19 Genotyped Healthy Male Japanese Study Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Japanese Participants
Keywords: Padsevonil
CYP2C19
Healthy Japanese Participants
Pharmacokinetics
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-08-30
Enrollment: 39
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil
timeFrame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
measure: Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
timeFrame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
measure: Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil
timeFrame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
measure: Terminal Half-life (t1/2) of a Single Dose Padsevonil
timeFrame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
measure: Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil
timeFrame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
measure: Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)
timeFrame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
measure: Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil
timeFrame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
measure: Terminal Half-life (t1/2) of Multiple Doses Padsevonil
timeFrame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
measure: Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)
timeFrame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
measure: Percentage of Participants With Treatment Emergent Adverse Events During the Study
timeFrame: From Baseline until the Safety Follow-up Visit (up to Day 21)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Up0083 001
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: