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

Healthy Volunteers Clinical Trial

Official title:

Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859078
• Other study ID #: 14609
• Secondary ID: I4V-MC-JAGL
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2013
• Last updated: August 23, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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• Have previously completed or withdrawn from this study or any other study investigating baricitinib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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Baricitinib
Administered orally
• Digoxin
Administered orally

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Digoxin		Predose up to 24 hours post Day 16 dose	No
Primary	Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (tmax) of Digoxin		Predose up to 24 hours post Day 16 dose	No
Primary	Pharmacokinetics (PK): Area Under the Concentration Curve During 1 Dosing Interval of Digoxin (AUCt)		Predose up to 24 hours post Day 16 dose	No
Secondary	Pharmacokinetics (PK): Amount of Drug Excreted Unchanged Over Each Urine Collection Interval (Ae) of Digoxin		0 to 24 hours post Day 16 dose	No
Secondary	Pharmacokinetics (PK): Renal Clearance (CLr) of Digoxin		0 to 24 hours post Day 16 dose	No