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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01859078
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Baricitinib Drug: Digoxin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

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 Name: LY3009104

Drug: Digoxin
Administered orally




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]
  2. PK: Maximum Concentration (Cmax) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]
  3. PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]

Secondary Outcome Measures :
  1. PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin [ Time Frame: 0 to 24 hours post-dose on Days 7 and 16 ]
  2. PK: Renal Clearance (CLr) of Digoxin [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT01859078


Locations
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United Kingdom
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01859078     History of Changes
Other Study ID Numbers: 14609
I4V-MC-JAGL ( Other Identifier: Eli Lilly and Company )
First Posted: May 21, 2013    Key Record Dates
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs