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Completed

NCT Number: NCT02226653

A Study of Evacetrapib in Healthy Japanese Participants

The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary 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.

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overtly healthy Japanese, as determined by medical history and physical examination
  • Have a body mass index (BMI) of 18.0 to 29.9 kg/m^2
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have an abnormal supine blood pressure as determined by the investigator
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Are women who are pregnant or lactating
  • Have used or intend to use over-the-counter, prescription medications, or herbal medicine 14 days prior to enrollment and during the study
  • Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
  • Are participants who currently smoke more than 10 cigarettes per day or are unwilling to abide by smoking restrictions

Treatment and study plan

Evacetrapib

Drug

Administered orally

Other names: LY2484595

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4

  2. PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4

Secondary outcomes

  1. PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5

  2. PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5

  3. PK: Cmax of Evacetrapib (Fasted and Fed)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Bioequivalence and Food Effect Study of Evacetrapib Evaluating a Single Tablet Compared to Two Tablets in Healthy Japanese Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2014
Registry last updated
Nov 8, 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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