Trial Outcomes & Findings for A Study of Baricitinib in Healthy Japanese Participants (NCT NCT02263911)
NCT ID: NCT02263911
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
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
Results posted on
2017-06-06
Participant Flow
Participant milestones
| Measure |
Baricitinib Dosing Sequence 1
Single oral dose of study drug daily on 5 occasions: Test Treatment 1 (T1) = Baricitinib 2 × 4 milligram (mg) commercial formulation tablets in a fasted state, Reference Treatment 1 (R1) = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, Test Treatment 2 (T2) = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, Reference Treatment 2 (R2) = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and (T2F) = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
|
Baricitinib Dosing Sequence 2
Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
|
Baricitinib Dosing Sequence 3
Single oral dose of study drug daily on 5 occasions: T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
|
Baricitinib Dosing Sequence 4
Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
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Period 1
STARTED
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COMPLETED
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COMPLETED
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Period 4 Washout
NOT COMPLETED
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Period 5
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COMPLETED
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Period 5
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Baricitinib in Healthy Japanese Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=16 Participants
All randomized participants.
|
|---|---|
|
Age, Continuous
|
36.8 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: All randomized participants.
Outcome measures
| Measure |
Baricitinib T1
n=16 Participants
Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
|
Baricitinib R1
n=16 Participants
Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib T2
n=16 Participants
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib R2
n=16 Participants
Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib T2F
n=16 Participants
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
|
|---|---|---|---|---|---|
|
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
|
584 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 20
|
297 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
301 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
254 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
PRIMARY outcome
Timeframe: 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-dosePopulation: All randomized participants.
Outcome measures
| Measure |
Baricitinib T1
n=16 Participants
Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
|
Baricitinib R1
n=16 Participants
Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib T2
n=16 Participants
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib R2
n=16 Participants
Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib T2F
n=16 Participants
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
|
|---|---|---|---|---|---|
|
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
|
580 ng*h/mL
Geometric Coefficient of Variation 20
|
294 ng*h/mL
Geometric Coefficient of Variation 17
|
298 ng*h/mL
Geometric Coefficient of Variation 17
|
251 ng*h/mL
Geometric Coefficient of Variation 14
|
PRIMARY outcome
Timeframe: 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-dosePopulation: All randomized participants.
Outcome measures
| Measure |
Baricitinib T1
n=16 Participants
Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
|
Baricitinib R1
n=16 Participants
Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib T2
n=16 Participants
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib R2
n=16 Participants
Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
|
Baricitinib T2F
n=16 Participants
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
|
|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Baricitinib
|
107 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
103 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
50.7 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
53.1 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
45.1 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
Adverse Events
Baricitinib T1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baricitinib R1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baricitinib T2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baricitinib R2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baricitinib T2F
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60