Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAE | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to evaluate the safety of the study drug known as LY2951742 in healthy Japanese and Caucasians. The study will also investigate how the body processes the drug and how the drug affects the body. The study is expected to last about 5 to 7 months, depending on the arm.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg LY2951742 Single Dose | Experimental | 5 mg LY2951742 given subcutaneously once |
|
| 50 mg LY2951742 Single Dose | Experimental | 50 mg LY2951742 given subcutaneously once |
|
| 120 mg LY2951742 Single Dose | Experimental | 120 mg LY2951742 given subcutaneously once |
|
| 300 mg LY2951742 Single Dose | Experimental | 300 mg LY2951742 given subcutaneously once |
|
| 300 mg LY2951742 Multiple Dose | Experimental | 300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W) |
|
| Placebo Single Dose | Placebo Comparator | Placebo given subcutaneously once |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2951742 | Drug | Administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section | Baseline through Day 197 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742 | Cmax was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified. | Day 1: Predose, 8 hr and 24 hour postdose |
| Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞]) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cypress | California | 90630 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31482569 | Derived | Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (SD) | 1 subcutaneous (SC) dose of placebo |
| FG001 | 5 mg LY2951742 Single Dose (SD) | 1 SC dose of 5 mg LY2951742 |
| FG002 | 50 mg LY2951742 (SD) | 1 SC dose of 50 mg LY2951742 |
| FG003 | 120 mg LY2951742 (SD) | 1 SC dose of 120 mg LY2951742 |
| FG004 | 300 mg LY2951742 (SD) | 1 SC dose of 300 mg LY2951742. |
| FG005 | Placebo Q4W | 3 SC doses of placebo every 4 Weeks (Q4W) |
| FG006 | 300 mg LY2951742 Q4W | 3 SC doses of 300 mg LY2951742 Q4W |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (SD) | 1 subcutaneous (SC) dose of placebo |
| BG001 | 5 mg LY2951742 Single Dose (SD) | 1 SC dose of 5 mg LY2951742 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Day 197 |
|
Not provided
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (SD) | 1 subcutaneous (SC) dose of placebo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628360 | galcanezumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Multiple Dose | Placebo Comparator | Placebo given subcutaneously once every 4 weeks (Q4W) |
|
| Placebo | Drug | Administered subcutaneously. |
|
AUC was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified. |
| Day 1: Predose, 8 hr and 24 hour postdose |
| United States |
| Withdrawal by Subject |
|
| BG002 | 50 mg LY2951742 (SD) | 1 SC dose of 50 mg LY2951742 |
| BG003 | 120 mg LY2951742 (SD) | 1 SC dose of 120 mg LY2951742 |
| BG004 | 300 mg LY2951742 (SD) | 1 SC dose of 300 mg LY2951742. |
| BG005 | Placebo Q4W | 3 SC doses of placebo every 4 Weeks (Q4W) |
| BG006 | 300 mg LY2951742 Q4W | 3 SC doses of 300 mg LY2951742 Q4W |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| 50 mg LY2951742 (SD) |
1 SC dose of 50 mg LY2951742 |
| OG003 | 120 mg LY2951742 (SD) | 1 SC dose of 120 mg LY2951742 |
| OG004 | 300 mg LY2951742 (SD) | 1 SC dose of 300 mg LY2951742. |
| OG005 | Placebo Q4W | 3 SC doses of placebo Q4W |
| OG006 | 300 mg LY2951742 Q4W | 3 SC doses of 300 mg LY2951742 Q4W |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742 | Cmax was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/millliliter (ng/mL) | Day 1: Predose, 8 hr and 24 hour postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞]) | AUC was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 8 hr and 24 hour postdose |
|
|
|
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | 5 mg LY2951742 Single Dose (SD) | 1 SC dose 5 mg of LY2951742 | 0 | 6 | 5 | 6 |
| EG002 | 50 mg LY2951742 (SD) | 1 SC dose 50 mg LY2951742 | 0 | 6 | 5 | 6 |
| EG003 | 120 mg LY2951742 (SD) | 1 SC dose 120 mg of LY2951742 | 0 | 7 | 6 | 7 |
| EG004 | 300 mg LY2951742 (SD) | 2 SC doses 300 mg of LY2951742 | 0 | 8 | 8 | 8 |
| EG005 | Placebo Q4W | 3 SC doses of placebo Q4W | 0 | 2 | 2 | 2 |
| EG006 | 300 mg LY2951742 Q4W | 3 SC doses of 300 mg LY2951742 Q4W | 0 | 8 | 7 | 8 |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |