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

Sponsor
Eli Lilly and Company
Study ID
NCT01859078
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Digoxin — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
May 31, 2013
Status verified
May 2017
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib + Digoxin
    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.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin [ Time Frame: Predose up to 24 hours post-dose on Days 7 and 16 ]

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