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Trial record 44 of 62 for:    Baricitinib

Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects

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ClinicalTrials.gov Identifier: NCT01299285
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : April 21, 2017
Last Update Posted : June 8, 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: Other
Condition Healthy Volunteers
Intervention Drug: LY3009104
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY3009104 (Baricitinib)
Hide Arm/Group Description Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title LY3009104
Hide Arm/Group Description Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
36.7  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
Asian 1
White 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces
Hide Description [Not Specified]
Time Frame Baseline up to 120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of total radioactivity
Urine 75.2  (6.74)
Feces 19.9  (4.92)
2.Secondary Outcome
Title Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
Hide Description [Not Specified]
Time Frame Baseline up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*nanomoles/liter(h*nmol/L)
1570
(28%)
3.Secondary Outcome
Title Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
Hide Description [Not Specified]
Time Frame Baseline up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*nanomole-equivalents/kilogram
1530
(31%)
4.Secondary Outcome
Title Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Baseline up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomoles/liter (nmol/L)
227
(36%)
5.Secondary Outcome
Title Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Baseline up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomole-equivalents/milliliter
231
(35%)
6.Secondary Outcome
Title Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Baseline up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hour
LY3009104
1.00
(1.00 to 2.00)
Radioactivity
1.00
(1.00 to 2.00)
7.Secondary Outcome
Title Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine
Hide Description Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report.
Time Frame Baseline up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of dose
LY3009104 68.5
Metabolite M3 0.9
Metabolite M10 1.0
Metabolite M22 3.2
8.Secondary Outcome
Title Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces
Hide Description Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report.
Time Frame Baseline up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104
Hide Arm/Group Description:
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of dose
LY3009104 14.8
Metabolite M12 0.9
9.Secondary Outcome
Title Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
Hide Description [Not Specified]
Time Frame Baseline up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title LY3009104 LY3009104 Metabolites
Hide Arm/Group Description:
The percentage of total radioactivity of LY3009104 (parent) in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: percentage of total radioactivity
1 hour 92.3 0
2 hour 94.5 0
4 hour 97.0 0
8 hour 91.2 0
24 hour 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY3009104
Hide Arm/Group Description Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
All-Cause Mortality
LY3009104
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY3009104
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY3009104
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Eye disorders   
Ocular hyperaemia  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01299285     History of Changes
Other Study ID Numbers: 14010
I4V-MC-JADG ( Other Identifier: Eli Lilly and Company )
First Submitted: February 16, 2011
First Posted: February 18, 2011
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 8, 2017