DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Digoxin

Pharmacokinetics (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 Digoxin

Pharmacokinetics (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- Have previously completed or withdrawn from this study or any other study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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017