A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

Sponsor
Eli Lilly and Company
Study ID
NCT02758613
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.

Study Details

The main purpose of this study is to investigate the safety and tolerability of the study drug known as baricitinib in healthy Chinese participants. The study will measure how the body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.

Key Dates

Start date
May 31, 2016
Status verified
Jul 2017
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 2 milligram (mg) Baricitinib
    2mg Baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
  • Experimental: 4mg Baricitinib
    4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
  • Experimental: 10mg Baricitinib
    10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
  • Placebo Comparator: Placebo
    Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).

Primary Outcome Measure

Number of Participants With One or More Clinically Significant Event(s) [ Time Frame: Baseline through Study Completion (up to Day 20) ]

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