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

Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Baricitinib; Drug: Digoxin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9LH
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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• Have previously completed or withdrawn from this study or any other study investigating baricitinib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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Baricitinib; Administered orally; Other Names: LY3009104; Drug: Digoxin; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: May 17, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: 14609; I4V-MC-JAGL (Other Identifier: Eli Lilly and Company)