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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005596-17 | EudraCT Number | ||
| I5V-MC-TGAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to investigate the safety and tolerability of LY3016859 administered as single doses, and to determine how long LY3016859 remains in the body
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo intravenous | Placebo Comparator | Placebo administered once intravenously |
|
| 0.1 milligram (mg) LY3016859 intravenous | Experimental | 0.1 mg LY3016859 administered once intravenously |
|
| 1 mg LY3016859 intravenous | Experimental | 1 mg LY3016859 administered once intravenously |
|
| 10 mg LY3016859 intravenous | Experimental | 10 mg LY3016859 administered once intravenously |
|
| 50 mg LY3016859 intravenous | Experimental | 50 mg LY3016859 administered once intravenously |
|
| 250 mg LY3016859 intravenous | Experimental | 250 mg LY3016859 administered once intravenously |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3016859 intravenous | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE) | Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section. | From baseline up to 8 weeks post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα) | Predose up to 8 weeks post dose | |
| Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin | Predose up to 8 weeks post dose |
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Inclusion Criteria:
Healthy men and women of non-childbearing potential as determined by medical history and physical examination (PE), and:
Are reliable and are willing to make themselves available for the duration of the study, and are willing to follow site specific study procedures
Must weigh greater than or equal to (≥) 50 kilograms (kg) at time of screening and dosing
Have clinical laboratory test results within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow blood sampling as per the protocol
Must be a non-smoker
Exclusion Criteria:
Are currently enrolled in, or have discontinued within the last 60 days from a clinical trial involving an investigational drug that has not received regulatory approval for any indication, or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
Have previously completed or withdrawn from this study or any other study investigating LY3016859, and have previously received the investigational product
Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator indicates a medical problem that would preclude study participation
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or have:
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or Hepatitis B and/or positive Hepatitis B surface antigen
Show use of any medication with potential to mask allergic response for example (e.g.) antihistamines, systemic glucocorticoids or antipyretic agents) within 3 days of dosing (Note: Acetaminophen or nonsteroidal analgesics for headache may be allowed as needed in the Investigator's judgment. The following medications are also specifically allowed in this study: vitamins at normal replacement doses, hormone replacement therapies e.g. estrogen, thyroid hormone), topical medications with limited systemic effects (e.g. eye drops, skin creams, vaginal antifungals, hemorrhoid preparations, etcetera (etc.), stable preventive therapies for hyperlipidemia and gastric acidity disorders)
Have donated blood of more than 500 milliliters (mL) within the last month.
Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol within 48 hours of entry into study and for the duration of the study [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
Have an abnormal blood pressure (sitting) defined as diastolic blood pressure (DBP) > 95 or less than (<) 50 millimeters of mercury (mmHg) and/or systolic blood pressure (SBP) > 150 or < 90 mmHg confirmed by at least 1 repeat measurement
Have evidence of regular use of known drugs of abuse or show positive findings for such use on urinary drug screening
Will donate blood or participate in another clinical trial within 3 months or 5 half-lives of study drug (whichever is longer) of receiving the last study drug administration
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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 |
|---|---|---|---|---|---|---|
| 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. | London | NW10 7EW |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo IV | Placebo administered once intravenously (IV). |
| FG001 | Placebo SC | Placebo administered once subcutaneously (SC). |
| FG002 | 0.1 mg LY3016859 IV | 0.1 milligram (mg) LY3016859 administered once intravenously. |
| FG003 | 1 mg LY3016859 IV | 1 mg LY3016859 administered once intravenously. |
| FG004 | 10 mg LY3016859 IV | 10 mg LY3016859 administered once intravenously. |
| FG005 | 50 mg LY3016859 IV | 50 mg LY3016859 administered once intravenously. |
| FG006 | 250 mg LY3016859 IV | 250 mg LY3016859 administered once intravenously. |
| FG007 | 750 mg LY3016859 IV | 750 mg LY3016859 administered once intravenously. |
| FG008 | 50 mg LY3016859 SC | 50 mg LY3016859 administered once subcutaneously. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo IV | Placebo administered once intravenously (IV). |
| BG001 | Placebo SC | Placebo administered once subcutaneously (SC). |
| 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 Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE) | Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section. | All randomized participants who received at least one dose of study drug. | Posted | Number | participants | From baseline up to 8 weeks post dose |
|
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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 | Placebo administered once intravenously (IV). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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|
| 750 mg LY3016859 intravenous | Experimental | 750 mg LY3016859 administered once intravenously |
|
| Placebo subcutaneous | Placebo Comparator | Placebo administered once subcutaneously |
|
| 50 mg LY3016859 subcutaneous | Experimental | 50 mg LY3016859 administered once subcutaneously |
|
| Placebo intravenous | Drug | Administered intravenously |
|
| LY3016859 subcutaneous | Drug | Administered subcutaneously |
|
| Placebo subcutaneous | Drug | Administered subcutaneously |
|
| Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859 | Predose up to 8 weeks post dose |
| Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf) | Predose up to 8 weeks post dose |
| United Kingdom |
| BG002 | 0.1 mg LY3016859 IV | 0.1 milligram (mg) LY3016859 administered once intravenously. |
| BG003 | 1 mg LY3016859 IV | 1 mg LY3016859 administered once intravenously. |
| BG004 | 10 mg LY3016859 IV | 10 mg LY3016859 administered once intravenously. |
| BG005 | 50 mg LY3016859 IV | 50 mg LY3016859 administered once intravenously. |
| BG006 | 250 mg LY3016859 IV | 250 mg LY3016859 administered once intravenously. |
| BG007 | 750 mg LY3016859 IV | 750 mg LY3016859 administered once intravenously. |
| BG008 | 50 mg LY3016859 SC | 50 mg LY3016859 administered once subcutaneously. |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Placebo administered once subcutaneously (SC). |
| OG002 | 0.1 mg LY3016859 IV | 0.1 milligram (mg) LY3016859 administered once intravenously. |
| OG003 | 1 mg LY3016859 IV | 1 mg LY3016859 administered once intravenously. |
| OG004 | 10 mg LY3016859 IV | 10 mg LY3016859 administered once intravenously. |
| OG005 | 50 mg LY3016859 IV | 50 mg LY3016859 administered once intravenously. |
| OG006 | 250 mg LY3016859 IV | 250 mg LY3016859 administered once intravenously. |
| OG007 | 750 mg LY3016859 IV | 750 mg LY3016859 administered once intravenously. |
| OG008 | 50 mg LY3016859 SC | 50 mg LY3016859 administered once subcutaneously. |
|
|
| Secondary | Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα) | All randomized participants who received at least one dose of study drug and had TGFα measurements. | Posted | Mean | Standard Deviation | hour*nanograms/milliliter (h*ng/mL) | Predose up to 8 weeks post dose |
|
|
|
| Secondary | Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin | All randomized participants who received at least one dose of study drug and had serum epiregulin measurements. | Posted | Mean | Standard Deviation | hour*picograms/milliliter (h*pg/mL) | Predose up to 8 weeks post dose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859 | All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to estimate Cmax. | Posted | Mean | Standard Deviation | nanograms/milliliter (ng/mL) | Predose up to 8 weeks post dose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf) | All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to calculate AUC0-inf. | Posted | Mean | Standard Deviation | hour*nanograms/milliliter (h*ng/mL) | Predose up to 8 weeks post dose |
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Placebo SC | Placebo administered once subcutaneously (SC). | 0 | 2 | 1 | 2 |
| EG002 | 0.1 mg LY3016859 IV | 0.1 milligram (mg) LY3016859 administered once intravenously. | 0 | 6 | 4 | 6 |
| EG003 | 1 mg LY3016859 IV | 1 mg LY3016859 administered once intravenously. | 0 | 6 | 3 | 6 |
| EG004 | 10 mg LY3016859 IV | 10 mg LY3016859 administered once intravenously. | 0 | 6 | 2 | 6 |
| EG005 | 50 mg LY3016859 IV | 50 mg LY3016859 administered once intravenously. | 0 | 6 | 2 | 6 |
| EG006 | 250 mg LY3016859 IV | 250 mg LY3016859 administered once intravenously. | 0 | 6 | 4 | 6 |
| EG007 | 750 mg LY3016859 IV | 750 mg LY3016859 administered once intravenously. | 0 | 6 | 3 | 6 |
| EG008 | 50 mg LY3016859 SC | 50 mg LY3016859 administered once subcutaneously. | 0 | 6 | 1 | 6 |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
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| Dry eyes | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
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