A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

Healthy Clinical Trial

Official title:

A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Particle Sizes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497391
• Other study ID #: 14629
• Secondary ID: I1V-MC-EIBA
• Status: Completed
• Phase: Phase 1
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: November 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 determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Overtly healthy participants of non-child bearing potential

• Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

• Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

• Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Evacetrapib
administered orally

Locations

Country	Name	City	State
Singapore	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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib		Predose on Day 1,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
Primary	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Evacetrapib		Predose on Day 1,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