A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants

Study Overview
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Brief Summary
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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 and well-tolerated baricitinib is when given at the same time as digoxin in healthy participants. This study will last approximately 3-4 weeks.

Official Title
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Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Baricitinib
* Drug: Digoxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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to 29.0 kilograms per square meter (kg/m^2) Exclusion Criteria: Women who are lactating Have previously completed or withdrawn from this study or any other study investigating baricitinib Currently enrolled in, have completed or discontinued within the last 90 days from a clinical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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricitinib + Digoxin<br>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. | Drug: Baricitinib<br>* Administered orally<br>* Other names: LY3009104;Drug: Digoxin<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin |  | Predose up to 24 hours post-dose on Days 7 and 16 | 
| PK: Maximum Concentration (Cmax) of Digoxin |  | Predose up to 24 hours post-dose on Days 7 and 16 | 
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin |  | Predose up to 24 hours post-dose on Days 7 and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin |  | 0 to 24 hours post-dose on Days 7 and 16 | 
| PK: Renal Clearance (CLr) of Digoxin | 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. | Predose to 24 hours post-dose on Days 7 and 16 |