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A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) 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: NCT01913314
Recruitment Status : Completed
First Posted : August 1, 2013
Results First Posted : August 7, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Intervention Drug: [^14C]-LY2835219
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description Single 150-milligram (mg) LY2835219 dose containing 5 micro- curies (µCi) of carbon-14-labeled LY2835219 ([^14C]-LY2835219), administered as an oral solution.
Period Title: Overall Study
Started 6
Received Study Drug 6
Completed 6
Not Completed 0
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
Participants who received study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years 0
Between 18 and 65 years 6
>=65 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female 3
Male 3
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino 1
Not Hispanic or Latino 5
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 0
White 6
More than one race 0
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Hide Description The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) * 100.
Time Frame Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage radioactive dose administered
Urine 3.43  (2.20)
Feces 81.0  (6.71)
2.Secondary Outcome
Title Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
LY2835219
63.7
(49%)
M20
30.9
(19%)
3.Secondary Outcome
Title Plasma PK of Radioactivity: Cmax
Hide Description [Not Specified]
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK Cmax data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram equivalents per gram (ng Eq/g)
123
(27%)
4.Secondary Outcome
Title Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and evaluable PK tmax data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: h
LY2835219
8.00
(6.00 to 8.00)
M20
8.00
(6.00 to 10.00)
Total Radioactivity
8.00
(6.00 to 10.00)
5.Secondary Outcome
Title Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)]
Hide Description [Not Specified]
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK AUC(0-tlast) data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
LY2835219
2310
(85%)
M20
1760
(43%)
6.Secondary Outcome
Title Plasma PK of Radioactivity: AUC(0 to Tlast)
Hide Description The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq*h/g).
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK AUC(0-tlast) data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng Eq*h/g
6580
(41%)
7.Secondary Outcome
Title Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)]
Hide Description [Not Specified]
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK AUC(0-∞) data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
LY2835219
2370
(83%)
M20
1830
(42%)
8.Secondary Outcome
Title Plasma PK of Radioactivity: AUC(0-∞)
Hide Description [Not Specified]
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng Eq*h/g
7010
(42%)
9.Secondary Outcome
Title Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces
Hide Description The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) * 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted.
Time Frame Predose through 216 h postdose; Fecal samples collected at 24-h intervals
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK data. No participants were analyzed for relative abundance of LY2835219 and metabolites of LY2835219 in urine.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of radioactive dose excreted
LY2835219 7
Metabolites 52
10.Secondary Outcome
Title Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma
Hide Description The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = [AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity] * 100.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK AUC(0-∞) data.
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description:
Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of total plasma radioactivity
LY2835219 34
Metabolites 44
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title [^14C]-LY2835219
Hide Arm/Group Description Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution.
All-Cause Mortality
[^14C]-LY2835219
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
[^14C]-LY2835219
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
[^14C]-LY2835219
Affected / at Risk (%) # Events
Total   4/6 (66.67%)    
General disorders   
Vessel Puncture Site Haematoma †  2/6 (33.33%)  2
Vessel Puncture Site Pain †  1/6 (16.67%)  1
Vessel Puncture Site Swelling †  1/6 (16.67%)  1
Infections and infestations   
Folliculitis †  1/6 (16.67%)  1
Injury, poisoning and procedural complications   
Excoriation †  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Pain in Extremity †  1/6 (16.67%)  1
Nervous system disorders   
Headache †  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Choking †  1/6 (16.67%)  1
†
Indicates events were collected by systematic assessment
[Not Specified]
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: NCT01913314    
Other Study ID Numbers: 14930
I3Y-MC-JPBD ( Other Identifier: Eli Lilly and Company )
First Submitted: July 30, 2013
First Posted: August 1, 2013
Results First Submitted: October 27, 2017
Results First Posted: August 7, 2018
Last Update Posted: January 7, 2019