Study of Food on Evacetrapib (LY2484595) in Healthy Participants

NCT01810432 | Completed Phase 1 Results

• 2 other identifiers: 14626I1V-MC-EIAX
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected. The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period. This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib

  Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

• PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib

  Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

• PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib

  Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Study Arms (2)

Evacetrapib (Fasted)

EXPERIMENTAL

130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.

Drug: Evacetrapib

Evacetrapib (Fed)

EXPERIMENTAL

130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.

Drug: Evacetrapib; Other: High-fat Meal

Interventions

Evacetrapib DRUG

Administered orally

Also known as: LY2484595

Evacetrapib (Fasted); Evacetrapib (Fed)

High-fat Meal OTHER

Administered orally, at breakfast.

Evacetrapib (Fed)

Eligibility Criteria

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

You may qualify if:

• Healthy participants as determined by medical history and physical examination
• Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
• Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

You may not qualify if:

• Have known allergies to evacetrapib, related compounds or any components of the formulation
• 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
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes

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.

Daytona Beach, Florida, 32117, United States

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: OTHER
• 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: March 11, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 12, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-10

Locations

US (1)