A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT02271425|
Recruitment Status : Completed
First Posted : October 22, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future.
In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection (given directly into a vein via a small needle).
The study is expected to last at least 15 days for each participant, not including screening. Screening will occur up to 28 days before the study drug is given.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Evacetrapib Tablet Drug: Evacetrapib Intravenous||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Absolute Bioavailability Study of Evacetrapib in Healthy Subjects Using the Intravenous Tracer Method|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: Evacetrapib Tablet + Evacetrapib Intravenous
A single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)[¹³C₈] evacetrapib administered over a 4 hour infusion.
Drug: Evacetrapib Tablet
Other Name: LY2484595
Drug: Evacetrapib Intravenous
Other Name: LY2484595
- Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271425
|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.|
|Leeds, West Yorkshire, United Kingdom, LS2 9LH|
|Study Director:||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|