Trial Outcomes & Findings for A Study of Baricitinib in Healthy Participants (NCT NCT03212638)
NCT ID: NCT03212638
Last Updated: 2019-03-26
Results Overview
PK: Cmax of baricitinib after a single oral dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose
Results posted on
2019-03-26
Participant Flow
Participant milestones
| Measure |
Part A: Sequence ABC
A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
With a 72 hour washout between doses
|
Part A: Sequence BCA
B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
With a 72 hour washout between doses
|
Part A: Sequence CAB
C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
With a 72 hour washout between doses
|
Part B: Sequence DE
D: 4 mg baricitinib suspension test formulation (TF) administered when fasting (TF fasting).
E:4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
With a 72 hour washout between doses
|
Part B:Sequence ED
E: 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
D: 4 mg baricitinib suspension test formulation (TF) administered when fasting. (TF fasting)
With a 72 hour washout between doses
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
8
|
0
|
0
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
8
|
8
|
8
|
0
|
0
|
|
Period 1
COMPLETED
|
8
|
8
|
8
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
8
|
8
|
8
|
0
|
0
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
8
|
8
|
8
|
0
|
0
|
|
Period 2
COMPLETED
|
8
|
8
|
8
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
8
|
8
|
8
|
0
|
0
|
|
Period 3
Received at Least 1 Dose of Study Drug
|
8
|
8
|
8
|
0
|
0
|
|
Period 3
COMPLETED
|
8
|
8
|
8
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
0
|
0
|
0
|
9
|
9
|
|
Period 4
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
9
|
9
|
|
Period 4
COMPLETED
|
0
|
0
|
0
|
9
|
9
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 5
STARTED
|
0
|
0
|
0
|
9
|
9
|
|
Period 5
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
9
|
9
|
|
Period 5
COMPLETED
|
0
|
0
|
0
|
9
|
9
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Baricitinib in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A:All Participants
n=24 Participants
All participants who received study drug during Part A.
|
Part B: All Participants
n=18 Participants
All participants who received study drug during Part B.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.14 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 2.55 • n=5 Participants
|
25.36 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 3.03 • n=7 Participants
|
24.5 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 2.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK parameters.
PK: Cmax of baricitinib after a single oral dose
Outcome measures
| Measure |
Part A: Baricitinib T1
n=24 Participants
4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
|
Part A: Baricitinib T2
n=24 Participants
4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
|
Part A: Baricitinib R
n=24 Participants
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
|
Part B: Baricitinib TF Fasted
n=17 Participants
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
|
Part B: Baricitinib TF Fed
n=18 Participants
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose
|
49.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
49.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
47.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
47.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
32.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK parameters.
PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng\*hr/mL)
Outcome measures
| Measure |
Part A: Baricitinib T1
n=24 Participants
4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
|
Part A: Baricitinib T2
n=24 Participants
4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
|
Part A: Baricitinib R
n=24 Participants
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
|
Part B: Baricitinib TF Fasted
n=17 Participants
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
|
Part B: Baricitinib TF Fed
n=18 Participants
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
|
|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose
|
314 ng*hr/mL
Geometric Coefficient of Variation 19
|
315 ng*hr/mL
Geometric Coefficient of Variation 17
|
216 ng*hr/mL
Geometric Coefficient of Variation 18
|
281 ng*hr/mL
Geometric Coefficient of Variation 22
|
273 ng*hr/mL
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK parameters.
PK: AUC(0-∞) of Baricitinib
Outcome measures
| Measure |
Part A: Baricitinib T1
n=24 Participants
4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
|
Part A: Baricitinib T2
n=24 Participants
4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
|
Part A: Baricitinib R
n=24 Participants
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
|
Part B: Baricitinib TF Fasted
n=17 Participants
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
|
Part B: Baricitinib TF Fed
n=18 Participants
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
|
|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose
|
319 ng*hr/mL
Geometric Coefficient of Variation 19
|
319 ng*hr/mL
Geometric Coefficient of Variation 17
|
319 ng*hr/mL
Geometric Coefficient of Variation 17
|
284 ng*hr/mL
Geometric Coefficient of Variation 22
|
282 ng*hr/mL
Geometric Coefficient of Variation 21
|
Adverse Events
Part A: Baricitinib T1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Baricitinib T2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Baricitinib R
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: Baricitinib TF Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Baricitinib TF Fed
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 |
Part A: Baricitinib T1
n=24 participants at risk
4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1).
|
Part A: Baricitinib T2
n=24 participants at risk
4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2).
|
Part A: Baricitinib R
n=24 participants at risk
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
|
Part B: Baricitinib TF Fasted
n=18 participants at risk
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
|
Part B: Baricitinib TF Fed
n=18 participants at risk
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed).
|
|---|---|---|---|---|---|
|
General disorders
Catheter site bruise
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
4.2%
1/24 • Number of events 2 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
5.6%
1/18 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
|
General disorders
Catheter site pain
|
8.3%
2/24 • Number of events 2 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
5.6%
1/18 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
|
General disorders
Catheter site swelling
|
8.3%
2/24 • Number of events 2 • Baseline through end of study (Up to 120 days)
|
4.2%
1/24 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
4.2%
1/24 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
5.6%
1/18 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
|
General disorders
Pain
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
5.6%
1/18 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
|
General disorders
Pyrexia
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
5.6%
1/18 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
22.2%
4/18 • Number of events 4 • Baseline through end of study (Up to 120 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
8.3%
2/24 • Number of events 2 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
0.00%
0/24 • Baseline through end of study (Up to 120 days)
|
5.6%
1/18 • Number of events 1 • Baseline through end of study (Up to 120 days)
|
0.00%
0/18 • Baseline through end of study (Up to 120 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place