A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Participants

NCT04013191 | Completed Phase 1 Results FDA Drug

• 1 other identifier: UP0053
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the plasma pharmacokinetic of padsevonil in adult and elderly study participants.

Conditions

Elderly Study Participants; Adult Study Participants

Keywords

Padsevonil; Phase 1; Pharmacokinetic

Outcome Measures

Primary Outcomes (5)

• The Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil (PSL)

  Cmax was measured in nanograms per milliliter (ng/mL).

  Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose

• The Area Under the Curve From 0 to t (AUC0-t) of a Single Dose Padsevonil (PSL)

  AUC0-t: area under the plasma concentration-time curve from time 0 to the last quantifiable concentration. It was measured in hours times nanograms per milliliter (h\*ng/mL).

  Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose

• The Area Under the Curve (AUC) of a Single Dose Padsevonil (PSL)

  AUC was measured in hours times nanograms per milliliter (h\*ng/mL).

  Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose

• The Maximum Plasma Concentration at Steady-state (Cmax, ss) of Multiple Doses Padsevonil (PSL)

  Cmax, ss was measured in nanograms per milliliter (ng/mL).

  Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13

• The Area Under the Curve (AUCtau) Over a Dosing Interval of Multiple Doses Padsevonil (PSL)

  AUCtau was measured in hours times nanograms per milliliter (h\*ng/mL).

  Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13

Secondary Outcomes (5)

• The Amount of Padsevonil (PSL) Excreted in Urine

  Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13

• The Ratio of Padsevonil (PSL) to Its Metabolites Excreted in Urine

  Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13

• Number of Participants With Treatment-emergent Adverse Events

  From Baseline until End-of-Treatment visit (up to Day 22)

• Number of Participants With Serious Adverse Events

  From Baseline until End-of-Treatment visit (up to Day 22)

• Number of Participants With Treatment-emergent Adverse Events Leading to Discontinuation of the Study

  From Baseline until End-of-Treatment visit (up to Day 22)

Study Arms (2)

Adult study participants

EXPERIMENTAL

Participants will receive assigned single and multiple doses of padsevonil.

Drug: Padsevonil

Elderly study participants

EXPERIMENTAL

Participants will receive assigned single and multiple doses of padsevonil.

Drug: Padsevonil

Interventions

Padsevonil DRUG

Padsevonil will be administered in predefined dosages.

Adult study participants; Elderly study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participants in the adult cohort must be ≥18 to 64 years of age at the time of signing the informed consent form (ICF)
• Study participants in the elderly cohort must be ≥65 years of age at the time of signing the ICF
• Study participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. In addition, elderly study participants must be considered to be in general good physical and mental health
• Study participants must have a body weight of at least 50 kg for males and 45 kg for females, and a body mass index within the range of 18 to 32 kg/m2 (inclusive)

You may not qualify if:

• Study participant has 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
• Study participant has a known hypersensitivity to any components of the study medication as stated in this protocol
• Subject has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
• Study participant has abnormal blood pressure
• Study participant has had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• Study participant has a lifetime history of suicide 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
• Study participant has past or intended use of over-the-counter or prescription medication, including herbal medications within 2 weeks or 5 half-lives prior to dosing
• The study participant has used hepatic enzyme-inducing drugs within 2 months prior to dosing
• Study participant has previously received padsevonil (PSL) in this or another study
• Study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.0x upper limit of normal (ULN)
• Study participant has bilirubin \>1.0xULN (isolated bilirubin \>1.0xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
• Study participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• Study participant has any clinically relevant electrocardiogram (ECG) finding at Screening or at Baseline. Study participant has an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any study participant with any of the following findings will be excluded: (a) QT interval corrected for heart rate using Bazett's formula (QTcB) or Fridericia's formula (QTcF) \>450 ms in study participants in 2 of 3 ECG recordings; (b) other conduction abnormalities (defined as PR interval ≥220 ms); (c) irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats. In case of an out of range result, 1 repeat will be allowed. If out of range again, the study participant cannot be included

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (1)

Up0053 001

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

padsevonil

Results Point of Contact

• Title: UCB
• Organization: Cares

clinicaltrials@ucb.com

+1844 599

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 9, 2019
• Study Start: July 9, 2019
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)