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Trial record 30 of 62 for:    Baricitinib

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

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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

Tracking Information
First Submitted Date  ICMJE May 17, 2013
First Posted Date  ICMJE May 21, 2013
Results First Submitted Date  ICMJE March 10, 2017
Results First Posted Date  ICMJE April 21, 2017
Last Update Posted Date June 6, 2017
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • 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 ]
  • PK: Maximum Concentration (Cmax) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]
  • PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Digoxin [ Time Frame: Predose up to 24 hours post Day 16 dose ]
  • Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (tmax) of Digoxin [ Time Frame: Predose up to 24 hours post Day 16 dose ]
  • Pharmacokinetics (PK): Area Under the Concentration Curve During 1 Dosing Interval of Digoxin (AUCτ) [ Time Frame: Predose up to 24 hours post Day 16 dose ]
Change History Complete list of historical versions of study NCT01859078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • 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 ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
  • Pharmacokinetics (PK): Amount of Drug Excreted Unchanged Over Each Urine Collection Interval (Ae) of Digoxin [ Time Frame: 0 to 24 hours post Day 16 dose ]
  • Pharmacokinetics (PK): Renal Clearance (CLr) of Digoxin [ Time Frame: 0 to 24 hours post Day 16 dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Official Title  ICMJE Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally
    Other Name: LY3009104
  • Drug: Digoxin
    Administered orally
Study Arms  ICMJE 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.

Interventions:
  • Drug: Baricitinib
  • Drug: Digoxin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2013)
33
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01859078
Other Study ID Numbers  ICMJE 14609
I4V-MC-JAGL ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP