Healthy Participants
Conditions
Brief summary
The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.
Interventions
DRUGLY2409021
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females as determined by medical history * Satisfactory clinical laboratory and physical examination tests * Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m\^2)
Exclusion criteria
\- Abnormal electrocardiograms (ECGs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose | Area under the concentration versus time curve from zero to infinity (AUC\[0-inf\]) of LY2409021 is presented. |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose | — |
| Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021 | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LY2409021 Single oral dose of 20 mg LY2409021. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | LY2409021 |
|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 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 | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
Area under the concentration versus time curve from zero to infinity (AUC\[0-inf\]) of LY2409021 is presented.
Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Population: All participants who received a dose of study drug and had evaluable AUC(0-inf) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2409021 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 | 48100 nanogram*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 28 |
Primary
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Population: All participants who received a dose of study drug and had evaluable Cmax data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2409021 | Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | 625 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
Primary
Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021
Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Population: All participants who received a dose of study drug and had evaluable Tmax data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LY2409021 | Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021 | 8.00 hours |