NCT05393076

Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Matched Control Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function. All participants in both cohorts (moderate hepatic impairment and matched healthy controls) will receive a single dose of the study drug, linerixibat. The purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) and safety of linerixibat.

Conditions

• Pruritus

Interventions

Type	Name	Description
DRUG	Linerixibat	Linerixibat dose and administration as per study intervention.

Timeline

• Start date: 2022-07-19
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2022-05-26
• Last updated: 2023-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study