NCT05435170

Food Effect Study of Linerixibat Tablets in Healthy Adult Participants

A Phase I, Randomized, Open-label, Single Dose, 2 Period, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Linerixibat Tablets in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants

Conditions

• Pruritus

Interventions

Type	Name	Description
DRUG	linerixibat	linerixibat will be administered per the treatment sequence

Timeline

• Start date: 2022-08-11
• Primary completion: 2022-10-10
• Completion: 2022-10-10
• First posted: 2022-06-28
• Last updated: 2022-11-29

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study