Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Healthy Chinese Participants (NCT NCT02758613)
NCT ID: NCT02758613
Last Updated: 2017-12-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Baseline through Study Completion (up to Day 20)
Results posted on
2017-12-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
2mg Baricitinib
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
4mg Baricitinib
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
10mg Baricitinib
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
|---|---|---|---|---|
|
Treatment
STARTED
|
8
|
8
|
9
|
8
|
|
Treatment
Received at Least One Dose of Study Drug
|
8
|
8
|
9
|
8
|
|
Treatment
COMPLETED
|
6
|
8
|
8
|
8
|
|
Treatment
NOT COMPLETED
|
2
|
0
|
1
|
0
|
|
Follow-up
STARTED
|
6
|
8
|
8
|
8
|
|
Follow-up
COMPLETED
|
6
|
8
|
8
|
8
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
2mg Baricitinib
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
4mg Baricitinib
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
10mg Baricitinib
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
|---|---|---|---|---|
|
Treatment
Physician and Sponsor Decision
|
1
|
0
|
0
|
0
|
|
Treatment
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Healthy Chinese Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
2mg Baricitinib
n=8 Participants
2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
4mg Baricitinib
n=9 Participants
4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
10mg Baricitinib
n=8 Participants
10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26.6 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
26.6 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
27.8 years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
22.34 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.21 • n=5 Participants
|
22.15 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.75 • n=7 Participants
|
21.87 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.28 • n=5 Participants
|
21.68 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.39 • n=4 Participants
|
22.01 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.38 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Study Completion (up to Day 20)Population: All randomized participants who received at least one dose of study drug and experienced clinically significant event.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
2mg Baricitinib
n=8 Participants
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
4mg Baricitinib
n=9 Participants
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
10mg Baricitinib
n=8 Participants
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
|---|---|---|---|---|
|
Number of Participants With One or More Clinically Significant Event(s)
|
4 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 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 PostdosePopulation: All randomized participants who received at least one dose of baricitinib and had evaluable PK data.
Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
2mg Baricitinib
n=9 Participants
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
4mg Baricitinib
n=8 Participants
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
10mg Baricitinib
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
|---|---|---|---|---|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib
Single Dose Day 1
|
24.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17
|
47.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
147 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
—
|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib
Multiple Dose Day 10
|
28.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
48.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
136 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17
|
—
|
SECONDARY outcome
Timeframe: 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 PostdosePopulation: All randomized participants who received at least 1 dose of baricitinib and had evaluable PK data.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
2mg Baricitinib
n=9 Participants
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
4mg Baricitinib
n=8 Participants
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
10mg Baricitinib
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
Single Dose Day 1
|
139 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 12
|
270 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
777 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 9
|
—
|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
Multiple Dose Day 10
|
145 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 12
|
265 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 18
|
771 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
2mg Baricitinib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
4mg Baricitinib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10mg Baricitinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
2mg Baricitinib
n=8 participants at risk
2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
4mg Baricitinib
n=9 participants at risk
4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
10mg Baricitinib
n=8 participants at risk
10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood uric acid increased
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
|
Investigations
Electrocardiogram abnormal
|
25.0%
2/8 • Number of events 6
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Protein urine present
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5079
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60