Healthy
Conditions
Brief summary
The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center.
Interventions
DRUGLY3832479
Administered IV.
DRUGPlacebo
Administered IV.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined by medical evaluation including medical history and physical examination
Exclusion criteria
* Test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) * Pregnant women and women of childbearing potential * Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk while taking the investigational product, or of interfering with the interpretation of data * Have participated in a clinical study involving an investigational product, with last dose within the past 30 days or 5 half-lives (whichever is longer) prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline through Follow-up (Week 12) | The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC\[0-∞\]) of LY3832479. |
| PK: Maximum Serum Concentration (Cmax) of LY3832479 | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 | PK: Maximum Serum Concentration (Cmax) of LY3832479. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo Participants received single Intravenous (IV) dose of Placebo. | 6 |
| 700 mg LY3832479 IV Participants received single IV dose of 700 mg LY3832479. | 7 |
| 2800 mg LY3832479 IV Participants received single IV dose of 2800 mg LY3832479. | 7 |
| 7000 mg LY3832479 IV Participants received single IV dose of 7000 mg LY3832479. | 6 |
| Total | 26 |
Baseline characteristics
| Characteristic | Pooled Placebo | Total | 7000 mg LY3832479 IV | 2800 mg LY3832479 IV | 700 mg LY3832479 IV |
|---|---|---|---|---|---|
| Age, Continuous | 42.8 Years STANDARD_DEVIATION 10.8 | 42.6 Years STANDARD_DEVIATION 9.3 | 45.7 Years STANDARD_DEVIATION 8.9 | 41.4 Years STANDARD_DEVIATION 11.2 | 41.0 Years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 11 Participants | 1 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 15 Participants | 5 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 16 Participants | 4 Participants | 6 Participants | 5 Participants |
| Region of Enrollment United States | 6 Participants | 26 Participants | 6 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 23 Participants | 6 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 3 / 6 | 2 / 7 | 2 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 | 0 / 7 | 0 / 6 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline through Follow-up (Week 12)
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled Placebo | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 0 Participants |
| 700 mg LY3832479 IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 0 Participants |
| 2800 mg LY3832479 IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 0 Participants |
| 7000 mg LY3832479 IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 0 Participants |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC\[0-∞\]) of LY3832479.
Time frame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | 4920 micrograms*day per milliliter(ug*day/mL) | Geometric Coefficient of Variation 23 |
| 700 mg LY3832479 IV | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | 22700 micrograms*day per milliliter(ug*day/mL) | Geometric Coefficient of Variation 22 |
| 2800 mg LY3832479 IV | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | 50800 micrograms*day per milliliter(ug*day/mL) | Geometric Coefficient of Variation 33 |
Secondary
PK: Maximum Serum Concentration (Cmax) of LY3832479
PK: Maximum Serum Concentration (Cmax) of LY3832479.
Time frame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | PK: Maximum Serum Concentration (Cmax) of LY3832479 | 244 ug/mL | Geometric Coefficient of Variation 24 |
| 700 mg LY3832479 IV | PK: Maximum Serum Concentration (Cmax) of LY3832479 | 1130 ug/mL | Geometric Coefficient of Variation 14 |
| 2800 mg LY3832479 IV | PK: Maximum Serum Concentration (Cmax) of LY3832479 | 2390 ug/mL | Geometric Coefficient of Variation 23 |