A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
Last updated on July 2021Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 46
Summary
- Conditions
- Epilepsy
- Healthy Participants
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: In Part 1 a single oral dose of padsevonil 200 mg for the 4 different product variants and the padsevonil reference tablet will be administered to all subjects in the fasted state in a randomized 5-way crossover design. In order to explore the food interaction with padsevonil, in Part 2 a single oral dose of a padsevonil reference tablet at dose levels of 200 mg and 400 mg (2x 200mg tablets) will be administered to all subjects in the fasted and fed state in a randomized 4-way crossover study.Masking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04283136
- Collaborators
- Not Provided
- Investigators
- Study Director: UCB Cares 001 844 599 2273 (UCB)
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