A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants

Pharmacokinetics of Evacetrapib (LY2484595) Following Administration to Subjects With Impaired Renal Function

The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment compared to participants with normal renal (kidney) function. This study will last approximately 8 weeks.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: Evacetrapib

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • 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.
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • 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:

• Female participants are not of child-bearing potential
• Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2)
• Participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance [CLcr] greater than or equal to 90 milliliters per minute [mL/min] at screening)
• Participants with severe renal impairment - estimated CLcr less than 30 mL/min at screening and are not undergoing hemodialysis

Exclusion Criteria:

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Participants who are unwilling to comply with the dietary requirements/restrictions during the study
• Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evacetrapib (Participants With Renal Impairment); Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment.	Drug: Evacetrapib; Other Names: LY2484595
Experimental: Evacetrapib (Healthy Participants); Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.	Drug: Evacetrapib; Other Names: LY2484595

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib	Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib	Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib	Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), 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 3, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: February 18, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Evacetrapib
• Other Study ID Numbers: 14620; I1V-MC-EIAR (Other Identifier: Eli Lilly and Company)