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

Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency
• Intervention / Treatment: Drug: Evacetrapib

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33169
      • 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, United States, 32806
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evacetrapib (Healthy); Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function	Drug: Evacetrapib; Other Names: LY2484595
Experimental: Evacetrapib (Hepatic, Mild); Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment	Drug: Evacetrapib; Other Names: LY2484595
Experimental: Evacetrapib (Hepatic, Moderate); Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment	Drug: Evacetrapib; Other Names: LY2484595
Experimental: Evacetrapib (Hepatic, Severe); Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment	Drug: Evacetrapib; Other Names: LY2484595

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Evacetrapib
• Other Study ID Numbers: 14621; I1V-MC-EIAS (Other Identifier: Eli Lilly and Company)