A Study of Evacetrapib in Healthy Japanese Participants

NCT02226653 | Completed Phase 1 Results

• 2 other identifiers: 14627I1V-JE-EIAY
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4

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

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4

Secondary Outcomes (3)

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

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5

• PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5

• PK: Cmax of Evacetrapib (Fasted and Fed)

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5

Study Arms (2)

Evacetrapib (reference)

EXPERIMENTAL

Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods

Drug: Evacetrapib

Evacetrapib (test)

EXPERIMENTAL

Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods

Drug: Evacetrapib

Interventions

Evacetrapib DRUG

Administered orally

Also known as: LY2484595

Evacetrapib (reference); Evacetrapib (test)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy Japanese, as determined by medical history and physical examination
• Have a body mass index (BMI) of 18.0 to 29.9 kg/m\^2
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

You may not qualify if:

• 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
• Have an abnormal supine 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
• Are women who are pregnant or lactating
• Have used or intend to use over-the-counter, prescription medications, or herbal medicine 14 days prior to enrollment and during the study
• Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks
• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
• Are participants who currently smoke more than 10 cigarettes per day or are unwilling to abide by smoking restrictions

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.

Fukuoka, 812-0025, Japan

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: August 25, 2014
• First Posted: August 27, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 8, 2018
• Results First Posted: October 10, 2018

Record last verified: 2018-10

Locations

JP (1)