A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT02365558|
Recruitment Status : Completed
First Posted : February 19, 2015
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.
There are two parts to the study. Participation in both parts will be required.
The study will last approximately 30 days, not including screening.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Evacetrapib Drug: Omeprazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Pharmacokinetics of Evacetrapib in Healthy Subjects|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Single oral dose of evacetrapib administered alone on Day 1 of Period 1.
Other Name: LY2484595
Experimental: Omeprazole + Evacetrapib
In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.
Evacetrapib will be co-administered once, orally on Day 14.
Other Name: LY2484595
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib [ Time Frame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose ]
- Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib [ Time Frame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose ]
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) [ Time Frame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 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): NCT02365558
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53704|
|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|