NCT01475136

A Study of LY2140023 in Hepatically-Impaired Participants

A Single Dose Pharmacokinetic Study of LY2140023 in Subjects With Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Denovo Biopharma LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).

Detailed description

The study included 4 groups, based on the Child-Pugh classification of hepatic impairment as follows: Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment (Child-Pugh class C).

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	LY2140023

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-11-21
• Last updated: 2021-09-22
• Results posted: 2021-09-22

Locations

2 sites across 2 countries: Germany, Hungary