A Study of Baricitinib and Omeprazole in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT01925144
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Omeprazole — DRUG
    Administered orally

Study Details

The main purpose of this study is to find out how the body will react to a study drug called baricitinib when taken with another drug called omeprazole. For each participant, this study will include 2 periods in fixed order. The study will last approximately 25 days, not including screening.

Key Dates

Start date
Oct 31, 2013
Status verified
May 2017
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib
    Baricitinib - 10 milligram (mg) tablet administered orally, once, on Day 1.
  • Experimental: Baricitinib + Omeprazole
    Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib [ Time Frame: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose ]

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