Healthy
Conditions
Brief summary
The purposes of this study are: * To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A) * To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous \[SC\]) (Part B). Information about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.
Interventions
DRUGGalcanezumab
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female healthy participants * Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive
Exclusion criteria
\- Currently smoke in excess of 5 cigarettes/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab. |
| Part A: Number of Participants With an Injection Site Adverse Event | Part A: Predose through 48 hours post dose | If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section. |
| Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP). |
| Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP). |
| Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP. |
| Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC\[0-tlast\]) of Plasma Calcitonin Gene Related Peptide (CGRP). |
| Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC \[0 to Tlast\]) of Plasma Calcitonin Gene Related Peptide (CGRP). |
| Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 240 mg Galcanezumab Solution - Part A Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection. | 15 |
| Placebo - Part A Participants received placebo by subcutaneous injection. | 3 |
| 300 mg Galcanezumab Lyophilized - Part B Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection. | 80 |
| 300 mg Galcanezumab Solution - Part B Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. | 80 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 2 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | 240 mg Galcanezumab Solution - Part A | Placebo - Part A | 300 mg Galcanezumab Lyophilized - Part B | 300 mg Galcanezumab Solution - Part B | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 12.1 | 45.7 years STANDARD_DEVIATION 14.5 | 38.5 years STANDARD_DEVIATION 11.4 | 40.6 years STANDARD_DEVIATION 12.8 | 40.5 years STANDARD_DEVIATION 12.44 |
| Basal Metabolic Index (BMI) | 26.27 Kilogram per square meter STANDARD_DEVIATION 3.86 | 30.67 Kilogram per square meter STANDARD_DEVIATION 4.32 | 27.57 Kilogram per square meter STANDARD_DEVIATION 4.14 | 27.55 Kilogram per square meter STANDARD_DEVIATION 3.97 | 27.56 Kilogram per square meter STANDARD_DEVIATION 4.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 43 Participants | 36 Participants | 85 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 4 Participants | 8 Participants | 13 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 | 8 Participants | 2 Participants | 30 Participants | 34 Participants | 74 Participants |
| Region of Enrollment United States | 15 participants | 3 participants | 80 participants | 80 participants | 178 participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 36 Participants | 38 Participants | 86 Participants |
| Sex: Female, Male Male | 6 Participants | 0 Participants | 44 Participants | 42 Participants | 92 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 / 15 | 0 / 3 | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 7 / 15 | 1 / 3 | 25 / 80 | 20 / 80 |
| serious Total, serious adverse events | 0 / 15 | 1 / 3 | 1 / 80 | 0 / 80 |
Outcome results
Primary
Part A: Number of Participants With an Injection Site Adverse Event
If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.
Time frame: Part A: Predose through 48 hours post dose
Population: All randomized participants who received at least one dose of study drug in Part A and had at least one post dose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 240 mg Galcanezumab - Part A | Part A: Number of Participants With an Injection Site Adverse Event | 3 Participants |
| Placebo - Part A | Part A: Number of Participants With an Injection Site Adverse Event | 0 Participants |
Primary
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug in part B and had evaluable Cmax PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 240 mg Galcanezumab - Part A | Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | 38 Microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 30 |
| Placebo - Part A | Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | 42.4 Microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 28 |
Primary
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug in Part B and had evaluable AUC zero to infinity PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 240 mg Galcanezumab - Part A | Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab | 1490 day*microgram per milliliter(day*μg/mL) | Geometric Coefficient of Variation 31 |
| Placebo - Part A | Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab | 1670 day*microgram per milliliter(day*μg/mL) | Geometric Coefficient of Variation 32 |
Secondary
Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC \[0 to Tlast\]) of Plasma Calcitonin Gene Related Peptide (CGRP).
Time frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable plasma AUC CGRP data in Part A.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 240 mg Galcanezumab - Part A | Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) | 231 day*ng/mL | Geometric Coefficient of Variation 48 |
Secondary
Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.
Time frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part A.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 240 mg Galcanezumab - Part A | Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | 2.64 ng/mL | Geometric Coefficient of Variation 34 |
Secondary
Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).
Time frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part A.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 240 mg Galcanezumab - Part A | Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | 56.01 Days |
Secondary
Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC\[0-tlast\]) of Plasma Calcitonin Gene Related Peptide (CGRP).
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable plasma AUC zero to tlast CGRP data in Part B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 240 mg Galcanezumab - Part A | Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) | 169 day*ng/mL | Geometric Coefficient of Variation 50 |
| Placebo - Part A | Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) | 192 day*ng/mL | Geometric Coefficient of Variation 50 |
Secondary
Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 240 mg Galcanezumab - Part A | Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | 2.19 ng/mL | Geometric Coefficient of Variation 36 |
| Placebo - Part A | Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | 2.38 ng/mL | Geometric Coefficient of Variation 34 |
Secondary
Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).
Time frame: Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 240 mg Galcanezumab - Part A | Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | 41.93 Days |
| Placebo - Part A | Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | 41.95 Days |