Clinical trial NCT01859078: A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Official title: Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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* Have previously completed or withdrawn from this study or any other study investigating baricitinib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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin
timeFrame: Predose up to 24 hours post-dose on Days 7 and 16
measure: PK: Maximum Concentration (Cmax) of Digoxin
timeFrame: Predose up to 24 hours post-dose on Days 7 and 16
measure: PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
timeFrame: Predose up to 24 hours post-dose on Days 7 and 16
Secondary outcomes:
measure: PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin
timeFrame: 0 to 24 hours post-dose on Days 7 and 16
measure: PK: Renal Clearance (CLr) of Digoxin
timeFrame: Predose to 24 hours post-dose on Days 7 and 16
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: 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.
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: