Status:
COMPLETED
A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effect of baricitinib on the levels of digoxin in the blood stream and how long it takes the body to remove digoxin. This study will also look at how safe...
Eligibility Criteria
Inclusion
- Are overtly healthy males or females, as determined by medical history and physical examination
- Women not of child-bearing potential
- Menopausal women
- Have a body mass index of 18.0 to 29.0 kilograms per square meter (kg/m\^2)
Exclusion
- Women who are lactating
- Have previously completed or withdrawn from this study or any other study investigating baricitinib
- Currently enrolled in, have completed or discontinued within the last 90 days from a clinical trial involving an investigational product
- Have a pulse rate less than 50 beats per minute (bpm) at screening
- Have a current or recent history (less than 30 days prior to screening and/or less than 45 days prior to Day -1) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
- Have an absolute neutrophil count less than 2000 cells/microliter (2×10\^9/liter) at screening or Day -1
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine
- Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study
- Have used or intend to use any drugs or substances that are known to be substrates, inducers, or inhibitors of P-glycoprotein (P-gp) within 30 days prior to dosing and throughout the study
- Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01859078
Start Date
May 1 2013
End Date
August 1 2013
Last Update
June 6 2017
Active Locations (1)
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1
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