Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAY | 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
The purpose of this study is to assess how fast galcanezumab gets into the blood stream and how long it takes the body to remove it. Information about side effects will be collected. The study is open to healthy Chinese participants. It will last up to about 24 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab | Experimental | Participants received single subcutaneous (SC) doses of 120 milligram (mg) or 240 mg Galcanezumab. |
|
| Placebo | Placebo Comparator | Participants received a single SC dose of Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab. | 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab. | 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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 |
|---|---|---|---|---|---|---|
| HuaShan Hospital Affiliated To Fudan University | Shanghai | Shanghai Municipality | 20040 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single Subcutaneous (SC) dose of Placebo. |
| FG001 | 120 mg Galcanezumab SC | Participants received a single SC dose of 120 milligram (mg) Galcanezumab. |
| FG002 | 240 mg Galcanezumab SC | Participants received a single SC dose of 240 mg Galcanezumab. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single Subcutaneous (SC) dose of Placebo. |
| BG001 | 120 mg Galcanezumab SC | Participants received a single SC dose of 120 milligram (mg) Galcanezumab. |
| 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 | Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab. | All randomized participants who received at least one dose of Galcanezumab. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose |
|
Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
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 | Participants received a single Subcutaneous (SC) dose of Placebo. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 22.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2019 | Apr 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2019 | Apr 1, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000628360 | galcanezumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered SC |
|
| BG002 | 240 mg Galcanezumab SC | Participants received a single SC dose of 240 mg Galcanezumab. |
| BG003 | 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 | No |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab. | All randomized participants who received at least one dose of Galcanezumab. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day per milliliter(μg*day/mL) | 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose |
|
|
|
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 120 mg Galcanezumab SC | Participants received a single SC dose of 120 milligram (mg) Galcanezumab. | 0 | 12 | 2 | 12 | 12 | 12 |
| EG002 | 240 mg Galcanezumab SC | Participants received a single SC dose of 240 mg Galcanezumab. | 0 | 12 | 1 | 12 | 12 | 12 |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Swelling face | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Bacterial test | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Lymphocyte percentage decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Monocyte percentage increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Neutrophil percentage increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary casts present | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 22.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided