Back to results

A Study of Evacetrapib in Participants With Abnormal Cholesterol

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Evacetrapib

About this trial

This is an interventional basic science trial for Dyslipidemia focused on measuring abnormal cholesterol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:
- Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
- Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
- Hypercholesterolemia on stable statin therapy for at least 3 month
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies or intolerance to evacetrapib, related compounds
Have history of recurrent rashes or chronic skin conditions
Have significant history of or current chronic, active inflammatory conditions
Have history or current evidence of significant neurological disorder
Have long-standing diabetes that is insulin requiring
Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery

Sites / Locations

Covance Clinical Research Inc
Covance
Covance Clinical Research Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Evacetrapib: Single Dose

Evacetrapib: Multiple Dose 12 Weeks

Evacetrapib: Multiple Dose 24 Weeks

Evacetrapib: Multiple Dose 52 Weeks

Arm Description

Single oral dose of evacetrapib on Day 1

Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks

Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks

Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])

PK Parameters of Evacetrapib: Maximum Concentration (Cmax)

PK Parameters of Evacetrapib: Terminal Half-life

Secondary Outcome Measures

PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level

PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level

PD Parameters of Evacetrapib: Total Cholesterol Level

PD Parameters of Evacetrapib: Triglyceride Level

Full Information

NCT ID

NCT02168803

First Posted

May 22, 2014

Last Updated

February 18, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02168803

Brief Title

A Study of Evacetrapib in Participants With Abnormal Cholesterol

Official Title

A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected. This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

abnormal cholesterol

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Evacetrapib: Single Dose

Arm Type

Experimental

Arm Description

Single oral dose of evacetrapib on Day 1

Arm Title

Evacetrapib: Multiple Dose 12 Weeks

Arm Type

Experimental

Arm Description

Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks

Arm Title

Evacetrapib: Multiple Dose 24 Weeks

Arm Type

Experimental

Arm Description

Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks

Arm Title

Evacetrapib: Multiple Dose 52 Weeks

Arm Type

Experimental

Arm Description

Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks

Intervention Type

Drug

Intervention Name(s)

Evacetrapib

Other Intervention Name(s)

LY2484595

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])

Time Frame

Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose

Title

PK Parameters of Evacetrapib: Maximum Concentration (Cmax)

Time Frame

Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose

Title

PK Parameters of Evacetrapib: Terminal Half-life

Time Frame

Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose

Secondary Outcome Measure Information:

Title

PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level

Time Frame

Day -1, Day 8

Title

PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level

Time Frame

Day -1, Day 8

Title

PD Parameters of Evacetrapib: Total Cholesterol Level

Time Frame

Day -1, Day 8

Title

PD Parameters of Evacetrapib: Triglyceride Level

Time Frame

Day -1, Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria: Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR Hypercholesterolemia on stable statin therapy for at least 3 month Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening Exclusion Criteria: Have known allergies or intolerance to evacetrapib, related compounds Have history of recurrent rashes or chronic skin conditions Have significant history of or current chronic, active inflammatory conditions Have history or current evidence of significant neurological disorder Have long-standing diabetes that is insulin requiring Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery

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

Covance Clinical Research Inc

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Covance

City

Dallas

State/Province

Texas

ZIP/Postal Code

75247

Country

United States

Facility Name

Covance Clinical Research Inc

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Evacetrapib in Participants With Abnormal Cholesterol

We'll reach out to this number within 24 hrs