Healthy Participants
Conditions
Brief summary
The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
Interventions
DRUGBaricitinib
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy Japanese male and female (women not of child-bearing potential or after menopause), as determined by medical history and physical examination * Have a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m\^2) * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion criteria
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study * Have an abnormal blood pressure as determined by the investigator * 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 * Are women who are pregnant or lactating * Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing and during the study. * Have donated blood of more than 400 milliliter (mL) in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males) or 800 mL (females) at screening. * Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions * Are participants who currently smoke more than 10 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by smoking restrictions * Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection * Have an absolute neutrophil count (ANC) less than 2000 cells/microliter (µL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose |
| PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose |
| PK: Maximum Concentration (Cmax) of Baricitinib | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All randomized participants. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 36.8 Years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 16 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Population: All randomized participants.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Baricitinib T1 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib | 626 nanogram*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 19 |
| Baricitinib R1 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib | 584 nanogram*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 20 |
| Baricitinib T2 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib | 297 nanogram*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 17 |
| Baricitinib R2 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib | 301 nanogram*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 17 |
| Baricitinib T2F | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib | 254 nanogram*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 14 |
Primary
PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Population: All randomized participants.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Baricitinib T1 | PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | 622 ng*h/mL | Geometric Coefficient of Variation 19 |
| Baricitinib R1 | PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | 580 ng*h/mL | Geometric Coefficient of Variation 20 |
| Baricitinib T2 | PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | 294 ng*h/mL | Geometric Coefficient of Variation 17 |
| Baricitinib R2 | PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | 298 ng*h/mL | Geometric Coefficient of Variation 17 |
| Baricitinib T2F | PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | 251 ng*h/mL | Geometric Coefficient of Variation 14 |
Primary
PK: Maximum Concentration (Cmax) of Baricitinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Population: All randomized participants.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Baricitinib T1 | PK: Maximum Concentration (Cmax) of Baricitinib | 107 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
| Baricitinib R1 | PK: Maximum Concentration (Cmax) of Baricitinib | 103 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 27 |
| Baricitinib T2 | PK: Maximum Concentration (Cmax) of Baricitinib | 50.7 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 25 |
| Baricitinib R2 | PK: Maximum Concentration (Cmax) of Baricitinib | 53.1 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 18 |
| Baricitinib T2F | PK: Maximum Concentration (Cmax) of Baricitinib | 45.1 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 31 |