Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 2 of 63 for:    Baricitinib

A Study of Baricitinib in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03212638
Recruitment Status : Completed
First Posted : July 11, 2017
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Baricitinib suspension
Drug: Baricitinib tablet
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: Sequence ABC Part A: Sequence BCA Part A: Sequence CAB Part B: Sequence DE Part B:Sequence ED
Hide Arm/Group Description

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

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

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

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

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 Title: Period 1
Started 8 8 8 0 0
Received at Least 1 Dose of Study Drug 8 8 8 0 0
Completed 8 8 8 0 0
Not Completed 0 0 0 0 0
Period Title: Period 2
Started 8 8 8 0 0
Received at Least 1 Dose of Study Drug 8 8 8 0 0
Completed 8 8 8 0 0
Not Completed 0 0 0 0 0
Period Title: Period 3
Started 8 8 8 0 0
Received at Least 1 Dose of Study Drug 8 8 8 0 0
Completed 8 8 8 0 0
Not Completed 0 0 0 0 0
Period Title: Period 4
Started 0 [1] 0 [1] 0 [1] 9 [2] 9 [2]
Received at Least 1 Dose of Study Drug 0 0 0 9 9
Completed 0 0 0 9 9
Not Completed 0 0 0 0 0
[1]
Participants were not allowed to participate in Part B and have completed study.
[2]
New Participants in Part B, no participants from Part A participated in Part B.
Period Title: Period 5
Started 0 0 0 9 9
Received at Least 1 Dose of Study Drug 0 0 0 9 9
Completed 0 0 0 9 9
Not Completed 0 0 0 0 0
Arm/Group Title Part A:All Participants Part B: All Participants Total
Hide Arm/Group Description All participants who received study drug during Part A. All participants who received study drug during Part B. Total of all reporting groups
Overall Number of Baseline Participants 24 18 42
Hide Baseline Analysis Population Description
All participants in Part A or Part B that received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 18 participants 42 participants
39.9  (8.5) 41.1  (11.3) 40.4  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 18 participants 42 participants
Female 1 0 1
Male 23 18 41
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 18 participants 42 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 24 18 42
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 18 participants 42 participants
American Indian or Alaska Native 0 0 0
Asian 24 17 41
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 0 0 0
More than one race 0 1 1
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Singapore Number Analyzed 24 participants 18 participants 42 participants
24 18 42
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms per meter squared (kg/m^2)
Number Analyzed 24 participants 18 participants 42 participants
24.14  (2.55) 25.36  (3.03) 24.5  (2.8)
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose
Hide Description PK: Cmax of baricitinib after a single oral dose
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable PK parameters.
Arm/Group Title Part A: Baricitinib T1 Part A: Baricitinib T2 Part A: Baricitinib R Part B: Baricitinib TF Fasted Part B: Baricitinib TF Fed
Hide Arm/Group Description:
4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
Overall Number of Participants Analyzed 24 24 24 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
49.8
(21%)
49.6
(24%)
47.8
(25%)
47.9
(22%)
32.5
(22%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Baricitinib T1, Part A: Baricitinib R
Comments Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.946 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part A: Baricitinib T2, Part A: Baricitinib R
Comments Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.944 to 1.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: Baricitinib TF Fasted, Part B: Baricitinib TF Fed
Comments Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.675
Confidence Interval (2-Sided) 95%
0.617 to 0.740
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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
Hide Description PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable PK parameters.
Arm/Group Title Part A: Baricitinib T1 Part A: Baricitinib T2 Part A: Baricitinib R Part B: Baricitinib TF Fasted Part B: Baricitinib TF Fed
Hide Arm/Group Description:
4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
Overall Number of Participants Analyzed 24 24 24 17 18
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
314
(19%)
315
(17%)
216
(18%)
281
(22%)
273
(20%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Baricitinib T1, Part A: Baricitinib R
Comments Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.996
Confidence Interval (2-Sided) 95%
0.963 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part A: Baricitinib T2, Part A: Baricitinib R
Comments Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.998
Confidence Interval (2-Sided) 95%
0.995 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: Baricitinib TF Fasted, Part B: Baricitinib TF Fed
Comments Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter ratio
Estimated Value 0.973
Confidence Interval (2-Sided) 95%
0.936 to 1.01
Estimation Comments [Not Specified]
3.Primary Outcome
Title PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose
Hide Description PK: AUC(0-∞) of Baricitinib
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable PK parameters.
Arm/Group Title Part A: Baricitinib T1 Part A: Baricitinib T2 Part A: Baricitinib R Part B: Baricitinib TF Fasted Part B: Baricitinib TF Fed
Hide Arm/Group Description:
4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
Overall Number of Participants Analyzed 24 24 24 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
319
(19%)
319
(17%)
319
(17%)
284
(22%)
282
(21%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Baricitinib T1, Part A: Baricitinib R
Comments Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.999
Confidence Interval (2-Sided) 95%
0.996 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part A: Baricitinib T2, Part A: Baricitinib R
Comments Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.999
Confidence Interval (2-Sided) 95%
0.966 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: Baricitinib TF Fasted, Part B: Baricitinib TF Fed
Comments Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.
Type of Statistical Test Equivalence
Comments 0.80, 1.25 as the bioequivalence boundaries
Method of Estimation Estimation Parameter ratio
Estimated Value 0.978
Confidence Interval (2-Sided) 95%
0.941 to 1.02
Estimation Comments [Not Specified]
Time Frame Baseline through end of study (Up to 120 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Baricitinib T1 Part A: Baricitinib T2 Part A: Baricitinib R Part B: Baricitinib TF Fasted Part B: Baricitinib TF Fed
Hide Arm/Group Description 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1). 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2). 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) 4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting). 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed).
All-Cause Mortality
Part A: Baricitinib T1 Part A: Baricitinib T2 Part A: Baricitinib R Part B: Baricitinib TF Fasted Part B: Baricitinib TF Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
Part A: Baricitinib T1 Part A: Baricitinib T2 Part A: Baricitinib R Part B: Baricitinib TF Fasted Part B: Baricitinib TF Fed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Baricitinib T1 Part A: Baricitinib T2 Part A: Baricitinib R Part B: Baricitinib TF Fasted Part B: Baricitinib TF Fed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/24 (8.33%)      1/24 (4.17%)      4/24 (16.67%)      1/18 (5.56%)      5/18 (27.78%)    
General disorders           
Catheter site bruise  1  0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  2 0/18 (0.00%)  0 1/18 (5.56%)  1
Catheter site pain  1  2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Catheter site swelling  1  2/24 (8.33%)  2 1/24 (4.17%)  1 1/24 (4.17%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Pain  1  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Pyrexia  1  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations           
Upper respiratory tract infection  1  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 4/18 (22.22%)  4
Musculoskeletal and connective tissue disorders           
Musculoskeletal pain  1  0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain  1  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: Clinicaltrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03212638    
Other Study ID Numbers: 14934
I4V-MC-JAGU ( Other Identifier: Eli Lilly and Company )
First Submitted: July 7, 2017
First Posted: July 11, 2017
Results First Submitted: October 26, 2018
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019