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

NCT01859078 | Completed Phase 1 Results

• 2 other identifiers: 14609I4V-MC-JAGL
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin

  Predose up to 24 hours post-dose on Days 7 and 16

• PK: Maximum Concentration (Cmax) of Digoxin

  Predose up to 24 hours post-dose on Days 7 and 16

• PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin

  Predose up to 24 hours post-dose on Days 7 and 16

Secondary Outcomes (2)

• PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin

  0 to 24 hours post-dose on Days 7 and 16

• PK: Renal Clearance (CLr) of Digoxin

  Predose to 24 hours post-dose on Days 7 and 16

Study Arms (1)

Baricitinib + Digoxin

EXPERIMENTAL

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.

Drug: Baricitinib; Drug: Digoxin

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib + Digoxin

Digoxin DRUG

Administered orally

Baricitinib + Digoxin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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• Have previously completed or withdrawn from this study or any other study investigating baricitinib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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Interventions

baricitinib; Digoxin

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 6, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

GB (1)