A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Healthy Chinese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Baricitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy Chinese males agreed to use methods of birth control or are postmenopausal Chinese females, as determined by medical history and physical examination Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), inclusive, at screening. Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site. Exclusion Criteria: Have a history of adverse drug reactions or drug allergy to more than 3 types of systemically administered medications. Have an abnormality in the 12-lead electrocardiogram (ECG). Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. Have a history of stomach or intestinal surgery. Current or recent history (<30 days prior to screening of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection. Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x 109/liter [L]). Have current herpes zoster or simplex within 90 days prior to the first dose, Have evidence of active or latent tuberculosis (TB) Have used or intend to use over-the-counter, prescription medication, or Chinese herbal preparation within 14 days prior to dosing and during the study. Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior to the first dose or are unwilling to abide by the grapefruit restrictions during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 milligram (mg) Baricitinib<br>2mg Baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;|
| Experimental: 4mg Baricitinib<br>4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;|
| Experimental: 10mg Baricitinib<br>10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;|
| Placebo Comparator: Placebo<br>Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Clinically Significant Event(s) | Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. | Baseline through Study Completion (up to Day 20) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib | Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing. | Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib | Area under the concentration versus time curve from zero to infinity (AUC0-inf) during single dose and area under the concentration versus time curve (AUCtau,ss) during multiple dose of baricitinib at steady state. | Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose |