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OpenTrials
Completed

NCT Number: NCT01859078

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating baricitinib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

Treatment and study plan

Baricitinib

Drug

Administered orally

Other names: LY3009104

Digoxin

Drug

Administered orally

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 21, 2013
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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