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

Phase 1

Completed

• Conditions: Hepatic Insufficiency
• Interventions: Drug: Evacetrapib

• Registration Number: NCT01836185
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-19
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2018-02-18
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Results First Posted: 2018-10-12
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evacetrapib (Hepatic, Severe)	Evacetrapib	Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment
Evacetrapib (Healthy)	Evacetrapib	Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function
Evacetrapib (Hepatic, Mild)	Evacetrapib	Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment
Evacetrapib (Hepatic, Moderate)	Evacetrapib	Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment

Primary Outcome Measures

Name	Time	Method
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
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) 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	tlast is defined as the last time point with a measurable concentration of Evacetrapib.
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

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.; 🇺🇸 Orlando, Florida, United States