A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Evacetrapib Tablet; Drug: Evacetrapib Intravenous

Study type: Interventional

Funder types: Industry

Identifiers

NCT02271425

14622

I1V-MC-EIAT (Other Identifier)

Details and patient eligibility

About

Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future.

In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection (given directly into a vein via a small needle).

The study is expected to last at least 15 days for each participant, not including screening. Screening will occur up to 28 days before the study drug is given.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy males or females, as determined by medical history and physical examination
• Female participants are post menopausal women or women not of child bearing potential due to surgical sterilization (at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal occlusion) confirmed by medical history, or menopause
• Have a body mass index (BMI) of less than 32 kilograms per square meter (kg/m^2)
• Have given written informed consent approved by Eli Lilly and Company and the ethical review board (ERB) governing the site

Exclusion criteria

• Have known allergies to evacetrapib, related compounds or any components of the formulation, intolerance to alcohol containing products, or history of significant allergic disease as determined by the investigator

• Have an abnormal 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

• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

• Are women who are pregnant or are lactating

• Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements/herbal medicine) 14 days prior to the first dose and during the study. The use of topical medicine, provided there is no evidence of chronic dosing with risk of systemic exposure, and occasional acetaminophen is acceptable

• Have donated blood of more than 500 milliliter (mL) within the last 3 months

• Are unwilling to comply with the dietary requirements/restrictions during the study:

  • Consume only the meals provided during the inpatient appointments,
  • Refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, Seville oranges, Seville orange juice, star fruit, pomelo, or commercial apple juice or orange juice for at least 7 days prior to the first dose

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Evacetrapib Tablet + Evacetrapib Intravenous

Experimental group

Description:

A single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)\[¹³C₈\] evacetrapib administered over a 4 hour infusion.

Treatment:

Drug: Evacetrapib Intravenous

Drug: Evacetrapib Tablet