NCT04136444

A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function

An Open-Label, Parallel-Group, Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal Hepatic Function or With Moderately Impaired Hepatic Function (Child-Pugh Class B)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the plasma pharmacokinetic (PK), safety and tolerability of padsevonil (PSL) in hepatically impaired and non-hepatically impaired study participants.

Conditions

• Healthy Study Participants
• Impaired Hepatic Function

Interventions

Type	Name	Description
DRUG	Padsevonil	Padsevonil will be administered in predefined dosages.

Timeline

• Start date: 2019-10-28
• Primary completion: 2020-05-22
• Completion: 2020-05-22
• First posted: 2019-10-23
• Last updated: 2021-07-28
• Results posted: 2021-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study