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Trial record 10 of 62 for:    Baricitinib

A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

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ClinicalTrials.gov Identifier: NCT01870388
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Liver Diseases
Hepatic Insufficiency
Intervention Drug: Baricitinib
Enrollment 16
Recruitment Details  
Pre-assignment Details An interim analysis was to be performed after ≤6 participants (pts) each in Group (G) 1 and G2 completed the study. If a <1.3-fold difference in exposure was seen between pts with moderate hepatic impairment (G2) and pts with normal hepatic function (G1), then pts with mild hepatic impairment (G3) were not to be enrolled. No pt was enrolled in G3.
Arm/Group Title Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment)
Hide Arm/Group Description Group 1: A single 4-milligram (mg) dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function. Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
Period Title: Overall Study
Started 8 8
Received 1 Dose of Study Drug 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment) Total
Hide Arm/Group Description Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function. Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B. Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  75.0%
8
 100.0%
14
  87.5%
>=65 years
2
  25.0%
0
   0.0%
2
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
1
  12.5%
1
  12.5%
2
  12.5%
Male
7
  87.5%
7
  87.5%
14
  87.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
5
  62.5%
3
  37.5%
8
  50.0%
Not Hispanic or Latino
3
  37.5%
5
  62.5%
8
  50.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  12.5%
0
   0.0%
1
   6.3%
White
7
  87.5%
8
 100.0%
15
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)
Hide Description [Not Specified]
Time Frame Predose up to 48 hours (h) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received 1 dose of study drug and had evaluable PK data.
Arm/Group Title Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment)
Hide Arm/Group Description:
Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with normal hepatic function.
Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with moderate hepatic impairment as classified by Child-Pugh B.
Overall Number of Participants Analyzed 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
35.3
(25%)
38.2
(23%)
2.Primary Outcome
Title PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib
Hide Description [Not Specified]
Time Frame Predose up to 48 h postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received 1 dose of study drug and had evaluable PK data.
Arm/Group Title Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment)
Hide Arm/Group Description:
Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
Overall Number of Participants Analyzed 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
295
(25%)
350
(28%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment)
Hide Arm/Group Description Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function. Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
All-Cause Mortality
Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baricitinib (Healthy Participants) Baricitinib (Moderate Hepatic Impairment)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/8 (25.00%)      4/8 (50.00%)    
Gastrointestinal disorders     
Nausea  1  0/8 (0.00%)  0 1/8 (12.50%)  1
Investigations     
Neutrophil count decreased  1  0/8 (0.00%)  0 1/8 (12.50%)  1
Nervous system disorders     
Dizziness  1  1/8 (12.50%)  1 1/8 (12.50%)  1
Headache  1  1/8 (12.50%)  1 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01870388     History of Changes
Other Study ID Numbers: 14600
I4V-MC-JAGC ( Other Identifier: Eli Lilly and Company )
First Submitted: June 3, 2013
First Posted: June 6, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017