Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate how much galcanezumab gets into the body after it is given as an injection just under the skin by two different devices. This study will measure how much galcanezumab reaches the blood stream and will test how it affects calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may occur will be collected. The study will last about 20 weeks for each participant. Screening is required within 45 days prior to the start of the study.
Interventions
BIOLOGICALGalcanezumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy as determined by medical history and physical examination * Have a body mass index (BMI) between 19.0 and 35.0 kilogram per meter square (kg/m²) * Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Exclusion criteria
* Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab * Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone * Intend to use over-the-counter or prescription medication within 7 days prior to dosing and during the study (especially systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, drugs with known hepatic toxicity, etc). Stable doses of hormone replacement therapy (HRT) are allowed for inclusion at the discretion of the investigator * Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab | 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab | 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\] of Galcanezumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) | Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose | Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) |
| Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP]) | Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose | Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from Time Zero to Time T, Where T is the Last Time Point with a Measurable Concentration of CGRP (AUC\[0-tlast, CGRP\]) |
Countries
United States
Participant flow
Recruitment details
Open label, randomized, parallel group with study drug administration on Day 1 and up to 20 weeks blood sampling.
Participants by arm
| Arm | Count |
|---|---|
| Galcanezumab Pre Filled Syringe (PFS) Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe. | 80 |
| Galcanezumab Autoinjector Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector. | 80 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Accidental drowning | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Galcanezumab Pre Filled Syringe (PFS) | Total | Galcanezumab Autoinjector |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 11.9 | 38.4 years STANDARD_DEVIATION 11.6 | 38.3 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 31 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 129 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 64 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 89 Participants | 46 Participants |
| Region of Enrollment United States | 80 Participants | 160 Participants | 80 Participants |
| Sex: Female, Male Female | 40 Participants | 81 Participants | 41 Participants |
| Sex: Female, Male Male | 40 Participants | 79 Participants | 39 Participants |
| Weight | 78.39 kilograms (kg) STANDARD_DEVIATION 14.34 | 80.00 kilograms (kg) STANDARD_DEVIATION 14.08 | 81.61 kilograms (kg) STANDARD_DEVIATION 13.72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 80 | 0 / 80 |
| other Total, other adverse events | 27 / 80 | 38 / 80 |
| serious Total, serious adverse events | 1 / 80 | 1 / 80 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\] of Galcanezumab
Time frame: 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose
Population: All participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Galcanezumab Pre Filled Syringe (PFS) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab | 1170 day*ug/mL | Geometric Coefficient of Variation 35 |
| Galcanezumab Autoinjector | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab | 1110 day*ug/mL | Geometric Coefficient of Variation 35 |
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
Time frame: 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose
Population: All participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Galcanezumab Pre Filled Syringe (PFS) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab | 31.5 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 40 |
| Galcanezumab Autoinjector | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab | 32.3 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 33 |
Secondary
Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP])
Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from Time Zero to Time T, Where T is the Last Time Point with a Measurable Concentration of CGRP (AUC\[0-tlast, CGRP\])
Time frame: Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose
Population: All participants who received at least 1 dose of study drug and had evaluable AUC\[0-tlast, CGRP\] PD data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Galcanezumab Pre Filled Syringe (PFS) | Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP]) | 242 day*ng/mL | Geometric Coefficient of Variation 50 |
| Galcanezumab Autoinjector | Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP]) | 242 day*ng/mL | Geometric Coefficient of Variation 58 |
Secondary
Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)
Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)
Time frame: Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose
Population: All participants who received at least 1 dose of study drug and had evaluable Cmax CGRP PD data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Galcanezumab Pre Filled Syringe (PFS) | Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) | 3.11 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 41 |
| Galcanezumab Autoinjector | Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) | 3.13 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 48 |