A Study of Evacetrapib (LY2484595) in Healthy Participants

NCT01903434 | Completed Phase 1 Results

• 2 other identifiers: 14623I1V-MC-EIAU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595)

  Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC\[0-∞\]) 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

Study Arms (2)

Evacetrapib -- Solid Fraction Test

EXPERIMENTAL

Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods

Drug: Evacetrapib

Evacetrapib -- Solid Fraction Reference

EXPERIMENTAL

Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods

Drug: Evacetrapib

Interventions

Evacetrapib DRUG

Administered orally

Also known as: LY2484595

Evacetrapib -- Solid Fraction Reference; Evacetrapib -- Solid Fraction Test

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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.

Evansville, Indiana, 47710, 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: 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 16, 2013
• First Posted: July 19, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-02

Locations

US (1)