A Study of Baricitinib in Healthy Japanese Participants

Sponsor
Eli Lilly and Company
Study ID
NCT02263911
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

Key Dates

Start date
Nov 30, 2014
Status verified
May 2017
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib Test Treatment 1 (T1)
    Single oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.
  • Experimental: Baricitinib Reference Treatment 1 (R1)
    Single oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.
  • Experimental: Baricitinib Test Treatment 2 (T2)
    Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.
  • Experimental: Baricitinib Reference Treatment 2 (R2)
    Single oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.
  • Experimental: Baricitinib Test Treatment 2 with Meal (T2F)
    Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib [ Time Frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose ]

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