Healthy Volunteers
Conditions
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
Interventions
DRUGLY2623091
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LY2623091 Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | LY2623091 |
|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
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)
Population: All participants who received study drug and had quantifiable levels of radioactivity in urine and feces.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2623091 | Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Feces | 60.5 percentage of radioactive dose recovered | Standard Deviation 4.27 |
| LY2623091 | Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urine | 1.39 percentage of radioactive dose recovered | Standard Deviation 0.454 |
Secondary
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
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)
Population: All participants who received study drug and had evaluable AUC(0-tlast) values.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2623091 | 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 | 11800 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 38 |
Secondary
Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091
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)
Population: All participants who received study drug and had evaluable AUC(0-inf) values.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2623091 | Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091 | 11800 ng*h/mL | Geometric Coefficient of Variation 38 |
Secondary
Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091
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)
Population: All participants who received study drug and had evaluable Cmax values.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2623091 | Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091 | 482 ng/mL | Geometric Coefficient of Variation 15 |
Secondary
Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces
Time frame: Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose
Population: All participants who received study drug and had evaluable plasma, urine, and fecal samples.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LY2623091 | Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces | Plasma | 7 metabolites |
| LY2623091 | Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces | Urine | NA metabolites |
| LY2623091 | Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces | Feces | 17 metabolites |