Healthy Volunteers
Conditions
Brief summary
The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants are overtly healthy male Japanese. * Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m\^2), inclusive.
Exclusion criteria
* Participants have known allergies to insulin peglispro or related compounds. * Participants have a fasting venous blood glucose \>108 milligrams per deciliter (mg/dL) (\>6 millimoles per liter \[mmol/L\]).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | — |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | AUC from time zero to infinity (AUC\[0-∞\]) of insulin peglispro was evaluated. |
| Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | — |
| Glucodynamics: Maximum Glucose Infusion Rate (Rmax) | Predose up to 36 hours post clamp procedure | — |
| Glucodynamics: Total Amount of Glucose Infused (Gtot) | Predose up to 36 hours post clamp procedure. | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insulin Peglispro Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Insulin Peglispro |
|---|---|
| Age, Continuous | 23.8 years STANDARD_DEVIATION 3.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 11 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Glucodynamics: Maximum Glucose Infusion Rate (Rmax)
Time frame: Predose up to 36 hours post clamp procedure
Population: All participants who received insulin peglispro and had evaluable Rmax data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | Glucodynamics: Maximum Glucose Infusion Rate (Rmax) | 1.75 milligrams/minute/kilogram (mg/min/kg) | Geometric Coefficient of Variation 30 |
Primary
Glucodynamics: Total Amount of Glucose Infused (Gtot)
Time frame: Predose up to 36 hours post clamp procedure.
Population: All participants who received insulin peglispro and had evaluable Gtot data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | Glucodynamics: Total Amount of Glucose Infused (Gtot) | 2180 milligrams/kilograms (mg/kg) | Geometric Coefficient of Variation 48 |
Primary
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro
AUC from time zero to infinity (AUC\[0-∞\]) of insulin peglispro was evaluated.
Time frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
Population: All participants who received insulin peglispro and had evaluable AUC(0-∞) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro | 280000 picomoles*hours/liter (pmol*h/L) | Geometric Coefficient of Variation 18 |
Primary
Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro
Time frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
Population: All participants who received insulin peglispro and had evaluable Cmax data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro | 3720 picomoles/liter (pmol/L) | Geometric Coefficient of Variation 32 |
Primary
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro
Time frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
Population: All participants who received insulin peglispro and had evaluable Tmax data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Insulin Peglispro | Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro | 39.00 hours |