Back to resultsA Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
Primary Purpose
Hepatic Insufficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Evacetrapib
Sponsored by
About this trial
This is an interventional basic science trial for Hepatic Insufficiency
Eligibility Criteria
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
Sites / Locations
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Evacetrapib (Healthy)
Evacetrapib (Hepatic, Mild)
Evacetrapib (Hepatic, Moderate)
Evacetrapib (Hepatic, Severe)
Arm Description
Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function
Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment
Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment
Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment
Outcomes
Primary Outcome Measures
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.
PK: Maximum Observed Concentration (Cmax) of Evacetrapib
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01836185
Brief Title
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
Official Title
Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evacetrapib (Healthy)
Arm Type
Experimental
Arm Description
Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function
Arm Title
Evacetrapib (Hepatic, Mild)
Arm Type
Experimental
Arm Description
Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment
Arm Title
Evacetrapib (Hepatic, Moderate)
Arm Type
Experimental
Arm Description
Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment
Arm Title
Evacetrapib (Hepatic, Severe)
Arm Type
Experimental
Arm Description
Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment
Intervention Type
Drug
Intervention Name(s)
Evacetrapib
Other Intervention Name(s)
LY2484595
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib
Description
tlast is defined as the last time point with a measurable concentration of Evacetrapib.
Time Frame
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
Title
PK: Maximum Observed Concentration (Cmax) of Evacetrapib
Time Frame
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
Title
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
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.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
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