Phase 1 Completed N=39 Basic Science

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

Healthy Japanese Participants

Source: ClinicalTrials.gov NCT04075409 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil — 1029; 833.6; 721.3 ng/mL

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil	1029; 833.6; 721.3	—
PRIMARY Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil	5988; 4645; 2823	—
PRIMARY Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil	6024; 4666; 2837	—
PRIMARY Terminal Half-life (t1/2) of a Single Dose Padsevonil	5.018; 5.904; 6.138	—
PRIMARY Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil	2.000; 3.000; 3.000	—
PRIMARY Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)	1375; 1318; 1263	—
PRIMARY Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil	6482; 6488; 4824	—
PRIMARY Terminal Half-life (t1/2) of Multiple Doses Padsevonil	NA; NA; NA	—
PRIMARY Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)	1.500; 2.000; 1.500	—
PRIMARY Percentage of Participants With Treatment Emergent Adverse Events During the Study	100; 100; 100; 100; 100; 100	—

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 450 mL) within the last 30 days prior to Screening. Blood donation during the study is not permitted

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04075409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.