Trial Outcomes & Findings for A Study of Baricitinib and Rifampicin in Healthy Participants (NCT NCT01910311)
NCT ID: NCT01910311
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Results posted on
2017-06-06
Participant Flow
This was an open-label, fixed-sequence, 2-period study conducted in healthy participants to compare the single dose pharmacokinetics (PK) of baricitinib when given alone and when coadministered with rifampicin.
Participant milestones
| Measure |
Baricitinib Then Baricitinib and Rifampicin
Period 1: 10-milligram (mg) dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally once daily (QD) on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
|
|---|---|
|
Period 1 (Days 1-2)
STARTED
|
18
|
|
Period 1 (Days 1-2)
Received Baricitinib
|
18
|
|
Period 1 (Days 1-2)
COMPLETED
|
18
|
|
Period 1 (Days 1-2)
NOT COMPLETED
|
0
|
|
Period 2 (Days 3-32)
STARTED
|
18
|
|
Period 2 (Days 3-32)
Received Baricitinib
|
18
|
|
Period 2 (Days 3-32)
Received At Least 1 Dose of Rifampicin
|
18
|
|
Period 2 (Days 3-32)
COMPLETED
|
18
|
|
Period 2 (Days 3-32)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Baricitinib and Rifampicin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Baricitinib Then Baricitinib and Rifampicin
n=18 Participants
Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
|
|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 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
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 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
United Kingdom
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.
Outcome measures
| Measure |
Baricitinib
n=18 Participants
Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
|
Baricitinib and Rifampicin
n=18 Participants
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
|
|---|---|---|
|
PK: Maximum Concentration (Cmax) of Baricitinib
|
96.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
101 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.
Outcome measures
| Measure |
Baricitinib
n=18 Participants
Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
|
Baricitinib and Rifampicin
n=18 Participants
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib
|
634 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 19
|
416 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and who had evaluable PK data.
Outcome measures
| Measure |
Baricitinib
n=18 Participants
Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
|
Baricitinib and Rifampicin
n=18 Participants
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
|
1.00 hours (h)
Interval 0.5 to 2.0
|
1.00 hours (h)
Interval 0.5 to 1.0
|
Adverse Events
Baricitinib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Rifampicin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Baricitinib and Rifampicin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baricitinib
n=18 participants at risk
A 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Adverse events (AEs) are reported from baseline through predose on Day 3.
|
Rifampicin
n=18 participants at risk
A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 9.
AEs are reported postdose on Day 3 through predose on Day 10.
|
Baricitinib and Rifampicin
n=18 participants at risk
A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 10 and 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
AEs are reported postdose on Day 10 up to Day 32.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
11.1%
2/18 • Number of events 2 • Baseline through study completion (up to Day 32)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 2 • Baseline through study completion (up to Day 32)
|
|
General disorders
Chest discomfort
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
General disorders
Fatigue
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
General disorders
Thirst
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
11.1%
2/18 • Number of events 2 • Baseline through study completion (up to Day 32)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 3 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
0.00%
0/18 • Baseline through study completion (up to Day 32)
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 32)
|
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