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Completed

NCT Number: NCT02168803

A Study of Evacetrapib in Participants With Abnormal Cholesterol

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evacetrapib

Drug

Administered orally

Other names: LY2484595

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

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

    Time frame: Day -1, Day 8

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

    Time frame: Day -1, Day 8

  3. PD Parameters of Evacetrapib: Total Cholesterol Level

    Time frame: Day -1, Day 8

  4. PD Parameters of Evacetrapib: Triglyceride Level

    Time frame: Day -1, Day 8

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 20, 2014
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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