Trial Outcomes & Findings for A Study of Baricitinib and Probenecid in Healthy Participants (NCT NCT01937026)
NCT ID: NCT01937026
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose
Results posted on
2017-06-06
Participant Flow
This was an open-label, 2-period, fixed-sequence study.
Participant milestones
| Measure |
Baricitinib
4 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, twice daily (BID), on Days 3 through 7 in Period 2.
|
|---|---|
|
Period 1 (Day 1 Through Predose Day 3)
STARTED
|
18
|
|
Period 1 (Day 1 Through Predose Day 3)
Received Baricitinib
|
18
|
|
Period 1 (Day 1 Through Predose Day 3)
COMPLETED
|
18
|
|
Period 1 (Day 1 Through Predose Day 3)
NOT COMPLETED
|
0
|
|
Period 2 (At Dosing Day 3 Through Day 8)
STARTED
|
18
|
|
Period 2 (At Dosing Day 3 Through Day 8)
Received Baricitinib
|
18
|
|
Period 2 (At Dosing Day 3 Through Day 8)
Received Probenecid on Days 3 Through 7
|
18
|
|
Period 2 (At Dosing Day 3 Through Day 8)
COMPLETED
|
18
|
|
Period 2 (At Dosing Day 3 Through Day 8)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Baricitinib and Probenecid in Healthy Participants
Baseline characteristics by cohort
| Measure |
Baricitinib
n=18 Participants
4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2.
|
|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 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
|
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
|
18 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: Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate Cmax of baricitinib.
Outcome measures
| Measure |
Baricitinib
n=18 Participants
4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
|
Baricitinib + Probenecid
n=18 Participants
4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
|
36.2 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
37.3 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdosePopulation: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.
Outcome measures
| Measure |
Baricitinib
n=18 Participants
4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
|
Baricitinib + Probenecid
n=18 Participants
4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2.
|
|---|---|---|
|
PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib
|
236 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 22
|
480 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
Adverse Events
Baricitinib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Probenecid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Baricitinib + Probenecid
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baricitinib
n=18 participants at risk
4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
Adverse events are reported from baseline through predose on Day 3.
|
Probenecid
n=18 participants at risk
1000 mg probenecid tablet administered orally, BID, on Days 3 through 4 in Period 2.
Adverse events are reported from postdose on Day 3 through predose on Day 5.
|
Baricitinib + Probenecid
n=18 participants at risk
4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 5 through 7 in Period 2.
Adverse events are reported from postdose on Day 5 up to Day 18.
|
|---|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
|
General disorders
Catheter site pain
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
General disorders
Fatigue
|
11.1%
2/18 • Number of events 2 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
|
General disorders
Pain
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
33.3%
6/18 • Number of events 6 • Baseline through study completion (up to Day 18).
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
0.00%
0/18 • Baseline through study completion (up to Day 18).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 18).
|
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