NCT01751399

A Single Dose Study of LY2605541 in Participants With Liver Impairment

A Single Dose Pharmacokinetic Study of LY2605541 in Subjects With Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to help answer the following research questions: * To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function * To assess the safety of LY2605541 and any side effects that might be associated with it

Detailed description

The study is conducted in 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

• Healthy Volunteers
• Hepatic Insufficiency
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	LY2605541

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-12-18
• Last updated: 2018-10-19
• Results posted: 2018-10-19

Locations

2 sites across 2 countries: Germany, Hungary