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Completed

NCT Number: NCT04075409

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

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

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Key information

Conditions

Healthy Japanese Participants

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Up0083 001

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Padsevonil

Drug

Padsevonil will be administered in predefined dosages.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil

    Time frame: 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)

    Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points.

  2. Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil

    Time frame: 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)

    AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.

  3. Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil

    Time frame: 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)

    AUC is the area under the plasma concentration-time curve from time zero to infinity.

  4. Terminal Half-life (t1/2) of a Single Dose Padsevonil

    Time frame: 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)

    The t1/2 is the apparent terminal half-life. Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).

  5. Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil

    Time frame: 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)

    The tmax is the time to reach maximum plasma concentration.

  6. Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)

    Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose

    Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state.

  7. Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil

    Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose

    AUCtau is the area under the plasma concentration time curve over a dosing interval.

  8. Terminal Half-life (t1/2) of Multiple Doses Padsevonil

    Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose

    The t1/2 is the apparent terminal half-life.

  9. Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)

    Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose

    The tmax, ss is the time of observed maximum plasma concentration at a steady-state.

  10. Percentage of Participants With Treatment Emergent Adverse Events During the Study

    Time frame: From Baseline until the Safety Follow-up Visit (up to Day 21)

    An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2019
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.