A Study of Evacetrapib (LY2484595) in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Tablet Solid Fractions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903434
• Other study ID #: 14623
• Secondary ID: I1V-MC-EIAU
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male participants who agree to use a reliable method of birth control and not donate sperm during the study and for 90 days after study completion

• Female participants who are not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause

• Have a body mass index of 18 to 32 kilograms per square meter (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:

• Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product

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

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders

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

• Are women who are pregnant or lactating

• Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during the study

• Have donated blood of more than 500 milliliters (mL) within the last month

• Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours prior to each dose and while resident at the Clinical Research Unit (CRU)

• Currently smoke or use tobacco or nicotine products

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Evacetrapib
Administered orally

Locations

Country	Name	City	State
United States	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.	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595)	The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).	Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Evacetrapib (LY2484595)	Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-8]) is summarized for each solid fraction control (Reference and Test).	Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period