A Study of Baricitinib in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations

Conditions
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Healthy

Intervention / Treatment
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* Drug: Baricitinib suspension
* Drug: Baricitinib tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or females, as determined by medical history and physical examination Women not of child-bearing potential Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²) inclusive, at screening Exclusion Criteria: Have received live vaccine(s) within 3 months of screening, or intend to during the study Have a current or recent history (less than [<] 30 days prior to screening and/or <45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricitinib T1 (Part A)<br>4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1) | Drug: Baricitinib suspension<br>* Administered orally<br>* Other names: LY3009104;|
| Experimental: Baricitinib T2 (Part A)<br>4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2) | Drug: Baricitinib suspension<br>* Administered orally<br>* Other names: LY3009104;|
| Experimental: Baricitinib R (Part A)<br>4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) | Drug: Baricitinib tablet<br>* Administered orally<br>* Other names: LY3009104;|
| Experimental: Baricitinib TF Fasted (Part B)<br>4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting) | Drug: Baricitinib suspension<br>* Administered orally<br>* Other names: LY3009104;|
| Experimental: Baricitinib TF Fed (Part B)<br>4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed) | Drug: Baricitinib suspension<br>* Administered orally<br>* Other names: LY3009104;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose | PK: Cmax of baricitinib after a single oral dose | 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 | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose | PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL) | 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 | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose | PK: AUC(0-∞) of Baricitinib | 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 |