Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGBaricitinib
Administered orally
DRUGOmeprazole
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy as determined by medical history and physical examination * Women not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or menopause * Have a body mass index of 18 to 29 kilograms per square meter (kg/m\^2), inclusive, at screening
Exclusion criteria
* Have known allergies to baricitinib, omeprazole, related compounds, or any components of the baricitinib or omeprazole formulations, or history of significant atopy * Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological (including clotting disorders), 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 an absolute neutrophil count (ANC) less than 2 × 10\^9 cells per liter (L) \[2000 cells/microliter (μL)\] at screening or Day -1. For abnormal values, a single repeat will be allowed * Intend to use over-the-counter or prescription medication (including drugs and substances known to alter gastric potential hydrogen (pH), such as proton pump inhibitors or over-the-counter antacid remedies and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of hormone replacement therapy (HRT) and occasional paracetamol, which will be permitted at the discretion of the investigator), or intended use of vitamin supplements from Day 1 until discharge from the clinical research unit (CRU) * Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of cytochrome P450 3A4 (CYP3A4) within 30 days prior to dosing and throughout the study * Are unable to tolerate or unwilling to undergo insertion of a nasogastric pH probe for assessment of gastric pH during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose |
| PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib | Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose |
Countries
United Kingdom
Participant flow
Pre-assignment details
This was an open-label, 2-period, fixed-sequence study.
Participants by arm
| Arm | Count |
|---|---|
| Baricitinib + Omeprazole 10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Baricitinib + Omeprazole |
|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 29 Participants |
| Region of Enrollment United Kingdom | 30 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 30 | 8 / 30 | 7 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
Population: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Cmax of baricitinib.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Baricitinib | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | 99.2 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 32 |
| Baricitinib + Omeprazole | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | 76.8 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 25 |
Primary
PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] 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
Population: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Baricitinib | PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib | 663 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 23 |
| Baricitinib + Omeprazole | PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib | 712 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 23 |
Primary
PK: Time of Maximum Observed Drug Concentration (Tmax) 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
Population: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Tmax of baricitinib.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baricitinib | PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | 1.00 hours |
| Baricitinib + Omeprazole | PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | 2.00 hours |