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

Phase 1

Completed

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

Recruitment & Eligibility

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Have previously completed or withdrawn from this study or any other study investigating baricitinib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

Arm && Interventions

Group	Intervention	Description
Baricitinib + Digoxin	Baricitinib	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.
Baricitinib + Digoxin	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.

Primary Outcome Measures

Name	Time	Method
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin	Predose up to 24 hours post-dose on Days 7 and 16
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

Secondary Outcome Measures

Name	Time	Method
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	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.

Locations (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.
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Leeds, West Yorkshire, United Kingdom