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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075409
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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

Condition or disease Intervention/treatment Phase
Healthy Japanese Participants Drug: Padsevonil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : September 30, 2019
Actual Primary Completion Date : December 27, 2019
Actual Study Completion Date : December 27, 2019

Arm Intervention/treatment
Experimental: Extensive metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
Drug: Padsevonil
Padsevonil will be administered in predefined dosages.

Experimental: Intermediate metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
Drug: Padsevonil
Padsevonil will be administered in predefined dosages.

Experimental: Poor metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
Drug: Padsevonil
Padsevonil will be administered in predefined dosages.




Primary Outcome Measures :
  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: Maximum observed plasma concentration

  2. Area under the curve from 0 to t (AUC0-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) ]
    AUC0-t: Area under the plasma concentration-time curve from time zero to time t

  3. Area under the curve from time 0 to infinity 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: Area under the plasma concentration time curve from zero up 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) ]
    t1/2: Apparent terminal half-life

  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) ]
    tmax: Time of observed maximum plasma concentration

  6. Maximum plasma concentration (Cmax) of padsevonil at steady-state [ Time Frame: Day 10: Predose and 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose (up to day 13) ]
    Cmax: Maximum observed plasma concentration

  7. Area under the curve over a dosing interval (AUCtau) for padsevonil at steady-state [ Time Frame: Day 10: Predose and 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose (up to day 13) ]
    AUCtau: Area under the plasma concentration time curve over a dosing interval

  8. Terminal half-life (t1/2) of padsevonil at steady-state [ Time Frame: Day 10: Predose and 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose (up to day 13) ]
    t1/2: Apparent terminal half-life

  9. Time to reach maximum concentration (tmax) for padsevonil at steady-state [ Time Frame: Day 10: Predose and 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose (up to day 13) ]
    tmax: Time of observed maximum plasma concentration

  10. Incidence of Adverse Events during the study [ Time Frame: From Screening until the Safety Follow-up Visit (up to Day 21) ]
    An Adverse Event is any untoward medical occurrence in a subject or trial subject 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075409


Locations
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Japan
Up0083 001
Tokyo, Japan
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT04075409    
Other Study ID Numbers: UP0083
JapicCTI-194958 ( Registry Identifier: JapicCTI )
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Padsevonil
CYP2C19
Healthy Japanese Participants
Pharmacokinetics