NCT01836185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
5 years until next milestone

Results Posted

Study results publicly available

October 12, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

April 17, 2013

Results QC Date

February 18, 2018

Last Update Submit

October 10, 2018

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

  • 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

  • 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

Study Arms (4)

Evacetrapib (Healthy)

EXPERIMENTAL

Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function

Drug: Evacetrapib

Evacetrapib (Hepatic, Mild)

EXPERIMENTAL

Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment

Drug: Evacetrapib

Evacetrapib (Hepatic, Moderate)

EXPERIMENTAL

Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment

Drug: Evacetrapib

Evacetrapib (Hepatic, Severe)

EXPERIMENTAL

Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment

Drug: Evacetrapib

Interventions

EvacetrapibDRUG
Also known as: LY2484595
Evacetrapib (Healthy)Evacetrapib (Hepatic, Mild)Evacetrapib (Hepatic, Moderate)Evacetrapib (Hepatic, Severe)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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.

Miami, Florida, 33169, United States

Location

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, 32806, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

evacetrapib

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 12, 2018

Results First Posted

October 12, 2018

Record last verified: 2018-10

Locations

US(2)