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Trial record 12 of 63 for:    Baricitinib

A Study of Baricitinib (LY3009104) in Healthy Chinese 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: NCT02758613
Recruitment Status : Completed
First Posted : May 2, 2016
Results First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Baricitinib
Drug: Placebo
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Hide Arm/Group Description Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). 2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). 4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). 10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Period Title: Treatment
Started 8 8 9 8
Received at Least One Dose of Study Drug 8 8 9 8
Completed 6 8 8 8
Not Completed 2 0 1 0
Reason Not Completed
Physician and Sponsor Decision             1             0             0             0
Withdrawal by Subject             1             0             1             0
Period Title: Follow-up
Started 6 8 8 8
Completed 6 8 8 8
Not Completed 0 0 0 0
Arm/Group Title Placebo 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib Total
Hide Arm/Group Description Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). 2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). 4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). 10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). Total of all reporting groups
Overall Number of Baseline Participants 8 8 9 8 33
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 9 participants 8 participants 33 participants
26.6  (5.4) 30.8  (7.3) 26.6  (3.5) 27.6  (6.7) 27.8  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 8 participants 33 participants
Female 0 0 0 0 0
Male 8 8 9 8 33
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 8 participants 33 participants
American Indian or Alaska Native 0 0 0 0 0
Asian 8 8 9 8 33
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 0 0 0 0 0
White 0 0 0 0 0
More than one race 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 8 participants 8 participants 9 participants 8 participants 33 participants
8 8 9 8 33
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 8 participants 8 participants 9 participants 8 participants 33 participants
22.34  (1.21) 22.15  (1.75) 21.87  (1.28) 21.68  (1.39) 22.01  (1.38)
1.Primary Outcome
Title Number of Participants With One or More Clinically Significant Event(s)
Hide Description Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Time Frame Baseline through Study Completion (up to Day 20)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and experienced clinically significant event.
Arm/Group Title Placebo 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Hide Arm/Group Description:
Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Overall Number of Participants Analyzed 8 8 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
4 0 2 4
2.Secondary Outcome
Title Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib
Hide Description Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing.
Time Frame Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of baricitinib and had evaluable PK data.
Arm/Group Title 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Hide Arm/Group Description:
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Overall Number of Participants Analyzed 8 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
Single Dose Day 1 Number Analyzed 8 participants 9 participants 8 participants
24.3
(17%)
47.8
(42%)
147
(28%)
Multiple Dose Day 10 Number Analyzed 8 participants 8 participants 8 participants
28.0
(24%)
48.0
(28%)
136
(17%)
3.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
Hide Description Area under the concentration versus time curve from zero to infinity (AUC0-inf) during single dose and area under the concentration versus time curve (AUCtau,ss) during multiple dose of baricitinib at steady state.
Time Frame Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of baricitinib and had evaluable PK data.
Arm/Group Title 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Hide Arm/Group Description:
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Overall Number of Participants Analyzed 8 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram * hour per milliliter (ng*h/mL)
Single Dose Day 1 Number Analyzed 8 participants 8 participants 8 participants
139
(12%)
270
(17%)
777
(9%)
Multiple Dose Day 10 Number Analyzed 8 participants 8 participants 8 participants
145
(12%)
265
(18%)
771
(14%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Hide Arm/Group Description Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). 2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). 4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). 10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
All-Cause Mortality
Placebo 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/9 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 2mg Baricitinib 4mg Baricitinib 10mg Baricitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/8 (50.00%)      1/8 (12.50%)      2/9 (22.22%)      4/8 (50.00%)    
Investigations         
Alanine aminotransferase increased  1  1/8 (12.50%)  1 0/8 (0.00%)  0 1/9 (11.11%)  1 2/8 (25.00%)  2
Aspartate aminotransferase increased  1  1/8 (12.50%)  1 0/8 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1
Blood bilirubin increased  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Blood creatine phosphokinase increased  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Blood triglycerides increased  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Blood uric acid increased  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Electrocardiogram abnormal  1  2/8 (25.00%)  6 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Neutrophil count decreased  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Protein urine present  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Vascular disorders         
Hypotension  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Orthostatic hypotension  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5079
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02758613    
Other Study ID Numbers: 14778
I4V-GH-JAGR ( Other Identifier: Eli Lilly and Company )
First Submitted: April 29, 2016
First Posted: May 2, 2016
Results First Submitted: July 11, 2017
Results First Posted: December 7, 2017
Last Update Posted: December 7, 2017