A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment

Hepatic Insufficiency Clinical Trial

Official title:

Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836185
• Other study ID #: 14621
• Secondary ID: I1V-MC-EIAS
• Status: Completed
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. This study will last approximately 28 days, not including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Participants have given written informed consent approved by the ethical review board (ERB) governing the site

• Female participants should be of non-childbearing potential

• Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)

• Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures

• Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion Criteria:

• Has had esophagus variceal bleeding within 3 months of check-in

• Have the need to take medications that may interfere with how the liver removes the drug

• Have evidence of cancer in the liver

• Consumes excessively large amounts of drinks with caffeine or alcohol

Related Conditions & MeSH terms

• Hepatic Insufficiency

Intervention

Drug:
• Evacetrapib

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Miami	Florida
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib	tlast is defined as the last time point with a measurable concentration of Evacetrapib.	Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
Primary	PK: Maximum Observed Concentration (Cmax) of Evacetrapib		Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
Primary	PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib		Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose