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Trial record 5 of 62 for:    Baricitinib

A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02340104
Recruitment Status : Completed
First Posted : January 16, 2015
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Baricitinib
Drug: [^13C4D3^15N]-baricitinib
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baricitinib
Hide Arm/Group Description Single oral dose of 4 mg baricitinib on Day 1 and approximately the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
42.8  (17.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
8
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 8 participants
8
 100.0%
1.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose
Hide Description AUC[0-∞] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng*h/mL).
Time Frame Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Baricitinib Oral Dose [^13C4D3^15N]-Baricitinib IV
Hide Arm/Group Description:
Single oral dose of 4 mg baricitinib
Single intravenous (IV) infusion of 4 µg[^13C4D3^15N]-baricitinib over 1.5 hours
Overall Number of Participants Analyzed 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
216
(27%)
0.274
(29%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baricitinib Oral Dose, [^13C4D3^15N]-Baricitinib IV
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 0.789
Confidence Interval (2-Sided) 90%
0.769 to 0.810
Estimation Comments Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib
Hide Arm/Group Description Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours
All-Cause Mortality
Baricitinib
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Baricitinib
Affected / at Risk (%) # Events
Total   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
Affected / at Risk (%) # Events
Total   2/8 (25.00%)    
General disorders   
Fatigue  1  1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/8 (12.50%)  1
Nervous system disorders   
Headache  1  1/8 (12.50%)  1
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
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: NCT02340104     History of Changes
Other Study ID Numbers: 14610
I4V-MC-JAGM ( Other Identifier: Eli Lilly and Company )
First Submitted: January 13, 2015
First Posted: January 16, 2015
Results First Submitted: March 10, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017