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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-MC-JVDT | Other Identifier | Eli Lilly and Company |
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This study evaluates a new formulation of ramucirumab, a drug approved for several types of cancer.
In this study of healthy participants, a small amount of ramucirumab will be given by injection either into a vein or just under the skin. Study doctors will measure the amount of ramucirumab in the bloodstream.
Side effects and tolerability will be documented. The study will last for about 16 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - Intravenous (IV) | Experimental | Participants received single dose of placebo administered IV. |
|
| 350 mg Ramucirumab IV | Placebo Comparator | Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion. |
|
| Placebo - Subcutaneous (SC) | Experimental | Participants received single dose of placebo administered SC. |
|
| 350 mg Ramucirumab SC (1x2 mL) | Placebo Comparator | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. |
|
| 350 mg Ramucirumab SC (2x2 mL) | Experimental | Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab - IV | Drug | Administered IV. |
|
|
| 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 | An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 90 |
| Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug | Number of participants showing ISRs when the drug was administered subcutaneously were reported. | Day 1 Predose through Day 90 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab | PK: AUC[0-∞] of Ramucirumab. | 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose |
| PK: Maximum Concentration (Cmax) of Ramucirumab | PK: Cmax of Ramucirumab | 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo IV | Participants received single dose of placebo administered Intravenously (IV). |
| FG001 | 350 mg Ramucirumab IV | Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion. |
| FG002 | Placebo SC | Participants received single dose of placebo administered subcutaneously (SC). |
| FG003 | 350 mg Ramucirumab SC (1x2 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. |
| FG004 | 350 mg Ramucirumab SC (2x2 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. |
| FG005 | 350 mg Ramucirumab SC (2x1 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. |
| FG006 | 700 mg Ramucirumab SC (2x2 mL) | Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo IV | Participants received single dose of placebo administered IV. |
| BG001 | 350 mg Ramucirumab IV | Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Day 90 |
|
Baseline up to Day 90
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo IV | Participants received single dose of placebo administered IV. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonsillar abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 21, 2020 | Feb 9, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2020 | Feb 9, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 350 mg Ramucirumab SC (2x1 mL) |
| Experimental |
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. |
|
| 700 mg Ramucirumab SC (2x2 mL) | Experimental | Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. |
|
| Placebo - IV | Drug | Administered IV. |
|
| Ramucirumab - SC | Drug | Administered SC. |
|
|
| Placebo - SC | Drug | Administered SC. |
|
| Physician Decision |
|
| BG002 | Placebo SC | Participants received single dose of placebo administered SC. |
| BG003 | 350 mg Ramucirumab SC (1x2 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. |
| BG004 | 350 mg Ramucirumab SC (2x2 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. |
| BG005 | 350 mg Ramucirumab SC (2x1 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. |
| BG006 | 700 mg Ramucirumab SC (2x2 mL) | Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. |
| 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 | No |
|
| OG000 |
| Placebo IV |
Participants received single dose of placebo administered IV. |
| OG001 | 350 mg Ramucirumab IV | Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion. |
| OG002 | Placebo SC | Participants received single dose of placebo administered SC. |
| OG003 | 350 mg Ramucirumab SC (1x2 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. |
| OG004 | 350 mg Ramucirumab SC (2x2 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. |
| OG005 | 350 mg Ramucirumab SC (2x1 mL) | Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. |
| OG006 | 700 mg Ramucirumab SC (2x2 mL) | Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. |
|
|
| Primary | Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug | Number of participants showing ISRs when the drug was administered subcutaneously were reported. | All participants who received at least one dose of study drug subcutaneously. | Posted | Count of Participants | Participants | No | Day 1 Predose through Day 90 |
|
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab | PK: AUC[0-∞] of Ramucirumab. | All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*microgram per milliliter (h*μg/mL) | 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose |
|
|
|
| Primary | PK: Maximum Concentration (Cmax) of Ramucirumab | PK: Cmax of Ramucirumab | All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose |
|
|
|
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 350 mg Ramucirumab IV | Participants received single 350 mg Ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG002 | Placebo SC | Participants received single dose of placebo administered SC. | 0 | 12 | 1 | 12 | 1 | 12 |
| EG003 | 350 mg Ramucirumab SC (1x2 mL) | Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG004 | 350 mg Ramucirumab SC (2x2 mL) | Participants received single 350 mg Ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. | 0 | 7 | 1 | 7 | 2 | 7 |
| EG005 | 350 mg Ramucirumab SC (2x1 mL) | Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG006 | 700 mg Ramucirumab SC (2x2 mL) | Participants received single 700 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. | 0 | 7 | 0 | 7 | 4 | 7 |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |