A Study of Baricitinib in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT03212638
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purposes of this study are to determine: * If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms. * How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body. * The safety and tolerability of baricitinib. The study has two parts. Individuals will participate in only one part. Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays. Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.

Key Dates

Start date
Jun 27, 2017
Status verified
Mar 2019
Primary completion
Jul 31, 2017
Completion
Nov 1, 2017

Study Design

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

Arms

  • Experimental: Baricitinib T1 (Part A)
    4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
  • Experimental: Baricitinib T2 (Part A)
    4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
  • Experimental: Baricitinib R (Part A)
    4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
  • Experimental: Baricitinib TF Fasted (Part B)
    4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)
  • Experimental: Baricitinib TF Fed (Part B)
    4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose [ Time Frame: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose ]

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