A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

NCT02497391 | Completed Phase 1 Results

• 2 other identifiers: 14629I1V-MC-EIBA
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) 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

Study Arms (3)

Evacetrapib Reference (R)

EXPERIMENTAL

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Drug: Evacetrapib

Evacetrapib Test 1 (T1)

EXPERIMENTAL

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Drug: Evacetrapib

Evacetrapib Test 2 (T2)

EXPERIMENTAL

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Drug: Evacetrapib

Interventions

Evacetrapib DRUG

administered orally

Also known as: LY2484595

Evacetrapib Reference (R); Evacetrapib Test 1 (T1); Evacetrapib Test 2 (T2)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 117597, Singapore

Location

MeSH Terms

Interventions

evacetrapib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2018
• Results First Posted: December 3, 2018

Record last verified: 2018-11

Locations

SG (1)