Trial Outcomes & Findings for A Study of Baricitinib and Omeprazole in Healthy Participants (NCT NCT01925144)
NCT ID: NCT01925144
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
Results posted on
2017-06-06
Participant Flow
This was an open-label, 2-period, fixed-sequence study.
Participant milestones
| Measure |
Baricitinib + Omeprazole
10 milligram (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, once daily (QD), for 8 days (Days 3 through 10) in Period 2.
|
|---|---|
|
Period 1 (Day 1 Through Predose Day 3)
STARTED
|
30
|
|
Period 1 (Day 1 Through Predose Day 3)
Received Baricitinib
|
30
|
|
Period 1 (Day 1 Through Predose Day 3)
COMPLETED
|
30
|
|
Period 1 (Day 1 Through Predose Day 3)
NOT COMPLETED
|
0
|
|
Period 2 (At Dosing Day 3 Through Day12)
STARTED
|
30
|
|
Period 2 (At Dosing Day 3 Through Day12)
Received Baricitinib
|
30
|
|
Period 2 (At Dosing Day 3 Through Day12)
Received 8 Doses of Omeprazole
|
30
|
|
Period 2 (At Dosing Day 3 Through Day12)
COMPLETED
|
30
|
|
Period 2 (At Dosing Day 3 Through Day12)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Baricitinib and Omeprazole in Healthy Participants
Baseline characteristics by cohort
| Measure |
Baricitinib + Omeprazole
n=30 Participants
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.
|
|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdosePopulation: 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.
Outcome measures
| Measure |
Baricitinib
n=30 Participants
10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
|
Baricitinib + Omeprazole
n=30 Participants
10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
|
99.2 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
76.8 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
PRIMARY outcome
Timeframe: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdosePopulation: 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.
Outcome measures
| Measure |
Baricitinib
n=30 Participants
10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
|
Baricitinib + Omeprazole
n=30 Participants
10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2.
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
|
1.00 hours
Interval 0.5 to 3.0
|
2.00 hours
Interval 0.75 to 6.0
|
PRIMARY outcome
Timeframe: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdosePopulation: 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.
Outcome measures
| Measure |
Baricitinib
n=30 Participants
10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
|
Baricitinib + Omeprazole
n=30 Participants
10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2.
|
|---|---|---|
|
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
|
712 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
Adverse Events
Baricitinib
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Omeprazole
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Baricitinib + Omeprazole
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baricitinib
n=30 participants at risk
10 mg baricitinib tablet administered orally once, on Day 1 in Period 1.
Adverse events are reported from baseline through predose on Day 3.
|
Omeprazole
n=30 participants at risk
40 mg omeprazole capsule administered orally, QD, on Days 3 through 9 in Period 2.
Adverse events are reported from postdose on Day 3 through predose on Day 10.
|
Baricitinib + Omeprazole
n=30 participants at risk
10 mg baricitinib tablet administered orally once with 40 mg omeprazole capsule orally once, on Day 10 in Period 2.
Adverse events are reported from postdose on Day 10 up to Day 24.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • Baseline through study completion (up to Day 24).
|
10.0%
3/30 • Number of events 3 • Baseline through study completion (up to Day 24).
|
0.00%
0/30 • Baseline through study completion (up to Day 24).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • Baseline through study completion (up to Day 24).
|
13.3%
4/30 • Number of events 4 • Baseline through study completion (up to Day 24).
|
6.7%
2/30 • Number of events 2 • Baseline through study completion (up to Day 24).
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • Number of events 1 • Baseline through study completion (up to Day 24).
|
6.7%
2/30 • Number of events 2 • Baseline through study completion (up to Day 24).
|
0.00%
0/30 • Baseline through study completion (up to Day 24).
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2 • Baseline through study completion (up to Day 24).
|
3.3%
1/30 • Number of events 1 • Baseline through study completion (up to Day 24).
|
0.00%
0/30 • Baseline through study completion (up to Day 24).
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 5 • Baseline through study completion (up to Day 24).
|
10.0%
3/30 • Number of events 3 • Baseline through study completion (up to Day 24).
|
20.0%
6/30 • Number of events 6 • Baseline through study completion (up to Day 24).
|
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