A Study of Baricitinib and Omeprazole in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT01925144|
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
The main purpose of this study is to find out how the body will react to a study drug called baricitinib when taken with another drug called omeprazole.
For each participant, this study will include 2 periods in fixed order. The study will last approximately 25 days, not including screening.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Baricitinib Drug: Omeprazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 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 Absorption of Baricitinib in Healthy Subjects|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Baricitinib - 10 milligram (mg) tablet administered orally, once, on Day 1.
Other Name: LY3009104
Experimental: Baricitinib + Omeprazole
Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).
Other Name: LY3009104
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib [ Time Frame: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose ]
- PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib [ Time Frame: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose ]
- PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib [ Time Frame: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 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): NCT01925144
|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|