A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Baricitinib (Drug); Digoxin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of DigoxinPharmacokinetics (PK): Time of Maximum Observed Drug Concentration (tmax) of Digoxin Pharmacokinetics (PK): Area Under the Concentration Curve During 1 Dosing Interval of Digoxin (AUCτ)
Secondary outcome: Pharmacokinetics (PK): Amount of Drug Excreted Unchanged Over Each Urine Collection Interval (Ae) of DigoxinPharmacokinetics (PK): Renal Clearance (CLr) of Digoxin
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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- Have previously completed or withdrawn from this study or any other study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
Locations and Contacts
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
Additional Information
Starting date: May 2013
Last updated: August 23, 2013
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