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

NCT ID: NCT04075409

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2019-12-27

Brief Summary

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

Conditions

Healthy Japanese Participants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Extensive metabolizers

Participants will receive assigned single and multiple doses of padsevonil.

Group Type: EXPERIMENTAL

Padsevonil

Intervention Type: DRUG

Padsevonil will be administered in predefined dosages.

Intermediate metabolizers

Participants will receive assigned single and multiple doses of padsevonil.

Group Type: EXPERIMENTAL

Padsevonil

Intervention Type: DRUG

Padsevonil will be administered in predefined dosages.

Poor metabolizers

Participants will receive assigned single and multiple doses of padsevonil.

Group Type: EXPERIMENTAL

Padsevonil

Intervention Type: DRUG

Padsevonil will be administered in predefined dosages.

Interventions

Padsevonil

Padsevonil will be administered in predefined dosages.

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Up0083 001

Tokyo, , Japan

Countries

Japan

References

Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9.

Reference Type: DERIVED

PMID: 38932723 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-194958

Identifier Type: REGISTRY

Identifier Source: secondary_id

UP0083

Identifier Type: -

Identifier Source: org_study_id