A Study of Baricitinib and Simvastatin in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT01960140|
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Baricitinib Drug: Simvastatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Multiple Baricitinib (LY3009104) Doses on the Pharmacokinetics of a Cytochrome P450 3A Substrate, Simvastatin, in Healthy Subjects|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Single oral dose of 40 milligrams (mg) simvastatin on Day 1.
Experimental: Baricitinib + Simvastatin
Oral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.
Other Name: LY3009104
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid [ Time Frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose ]The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.
- PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid [ Time Frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose ]The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.
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): NCT01960140
|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|