A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT01859078|
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Baricitinib Drug: Digoxin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Baricitinib + Digoxin
Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.
Baricitinib - 10 mg administered orally, QD, on Days 8 through 16.
Other Name: LY3009104
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]
- PK: Maximum Concentration (Cmax) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]
- PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]
- PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin [ Time Frame: 0 to 24 hours post-dose on Days 7 and 16 ]
- PK: Renal Clearance (CLr) of Digoxin [ Time Frame: Predose to 24 hours post-dose on Days 7 and 16 ]CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ.
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): NCT01859078
|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|