Clinical trial NCT01825889: A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
Official title: Pharmacokinetics of Evacetrapib (LY2484595) Following Administration to Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib
timeFrame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
Secondary outcomes:
measure: Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib
timeFrame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
Other outcomes:
Locations:
city: Miami
country: United States
facility: 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.
state: Florida
city: Orlando
country: United States
facility: 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.
state: Florida
city: Saint Paul
country: United States
facility: 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.
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: