A Study of How the Body Breaks Down and Eliminates LY2623091
Study Details
Study Description
Brief Summary
This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY2623091 Single oral dose of LY2623091 |
Drug: LY2623091
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)]
Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.
Secondary Outcome Measures
- Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 [Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)]
- Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091 [Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)]
- Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091 [Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)]
- Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces [Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Overtly healthy males; as determined by physical examination, clinical laboratory tests, medical history and electrocardiograms (ECGs).
-
With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.
Exclusion Criteria:
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madison | Wisconsin | United States |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15517
- I7T-MC-RMAA
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | LY2623091 |
---|---|
Arm/Group Description | Single dose of 25 milligrams (mg) LY2623091 containing carbon-14 [¹⁴C]-LY2623091 (approximately 100 microcuries [µCi]) administered orally. |
Period Title: Overall Study | |
STARTED | 6 |
Received Study Drug | 6 |
COMPLETED | 5 |
NOT COMPLETED | 1 |
Baseline Characteristics
Arm/Group Title | LY2623091 |
---|---|
Arm/Group Description | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
Overall Participants | 6 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
40
(14.0)
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
6
100%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
6
100%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
1
16.7%
|
Black or African American |
0
0%
|
White |
5
83.3%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
6
100%
|
Outcome Measures
Title | Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
---|---|
Description | Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals. |
Time Frame | Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received study drug and had quantifiable levels of radioactivity in urine and feces. |
Arm/Group Title | LY2623091 |
---|---|
Arm/Group Description | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
Measure Participants | 6 |
Feces |
60.5
(4.27)
|
Urine |
1.39
(0.454)
|
Title | Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 |
---|---|
Description | |
Time Frame | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received study drug and had evaluable AUC(0-tlast) values. |
Arm/Group Title | LY2623091 |
---|---|
Arm/Group Description | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
Measure Participants | 6 |
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hour/milliliter (ng*h/mL)] |
11800
(38)
|
Title | Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091 |
---|---|
Description | |
Time Frame | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received study drug and had evaluable AUC(0-inf) values. |
Arm/Group Title | LY2623091 |
---|---|
Arm/Group Description | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
Measure Participants | 6 |
Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL] |
11800
(38)
|
Title | Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091 |
---|---|
Description | |
Time Frame | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received study drug and had evaluable Cmax values. |
Arm/Group Title | LY2623091 |
---|---|
Arm/Group Description | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
Measure Participants | 6 |
Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
482
(15)
|
Title | Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces |
---|---|
Description | |
Time Frame | Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received study drug and had evaluable plasma, urine, and fecal samples. |
Arm/Group Title | LY2623091 |
---|---|
Arm/Group Description | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
Measure Participants | 6 |
Plasma |
7
|
Urine |
NA
|
Feces |
17
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality. | |
Arm/Group Title | LY2623091 | |
Arm/Group Description | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. | |
All Cause Mortality |
||
LY2623091 | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
LY2623091 | ||
Affected / at Risk (%) | # Events | |
Total | 0/6 (0%) | |
Other (Not Including Serious) Adverse Events |
||
LY2623091 | ||
Affected / at Risk (%) | # Events | |
Total | 4/6 (66.7%) | |
Gastrointestinal disorders | ||
Constipation | 1/6 (16.7%) | 1 |
Diarrhoea | 1/6 (16.7%) | 1 |
Proctalgia | 1/6 (16.7%) | 1 |
General disorders | ||
Vessel puncture site bruise | 1/6 (16.7%) | 1 |
Injury, poisoning and procedural complications | ||
Scratch | 1/6 (16.7%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Neck pain | 1/6 (16.7%) | 1 |
Nervous system disorders | ||
Headache | 1/6 (16.7%) | 2 |
Skin and subcutaneous tissue disorders | ||
Erythema | 1/6 (16.7%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
- 15517
- I7T-MC-RMAA