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

Phase 1

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: Evacetrapib

• Registration Number: NCT01825889
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2018-02
• Results First Submitted: 2018-02-18
• Results First Submitted QC: 2018-02-18
• Last Update Submitted: 2018-02-18
• Results First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evacetrapib (Participants With Renal Impairment)	Evacetrapib	Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment.
Evacetrapib (Healthy Participants)	Evacetrapib	Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

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.; 🇺🇸 Saint Paul, Minnesota, United States