A Study of Evacetrapib in Japanese and Non-Japanese Participants
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|ClinicalTrials.gov Identifier: NCT01958489|
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.
This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Evacetrapib Drug: Pravastatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non-Japanese Subjects|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Single 40 milligram (mg) oral dose of pravastatin administered on Day 1.
Experimental: Evacetrapib + Pravastatin
Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.
Other Name: LY2484595
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin [ Time Frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose ]
- PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin [ Time Frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose ]
- PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin [ Time Frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose ]
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): NCT01958489
|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|