Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAA | 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
To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose 1 milligram (mg) LY2951742 | Experimental | Administered single subcutaneous injection |
|
| Single dose 5 mg LY2951742 | Experimental | Administered single subcutaneous injection |
|
| Single dose 25 mg LY2951742 | Experimental | Administered single subcutaneous injection |
|
| Single dose 75 mg LY2951742 | Experimental | Administered single subcutaneous injection |
|
| Single dose 200 mg LY2951742 | Experimental | Administered single subcutaneous injection |
|
| Single dose 600 mg LY2951742 | Experimental | Administered single subcutaneous injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2951742 | Drug | Administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module. | Baseline up to 6 months (study completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax) | Day 1 up to Day 84 or early discontinuation | |
| Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC) | Day 1 up to Day 84 or early discontinuation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study investigating LY2951742
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 including QTc greater than 450 milliseconds (msec) (male), history of congenital long QT syndrome or other conduction abnormality
Have abnormal vital signs as determined by the investigator
Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders (including migraine) that would constitute a risk when taking the study medication; or of interfering with the interpretation of data study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of:
Intend to use over-the-counter or prescription medication that may interfere with study safety assessments or other measurements within 7 days prior to dosing and during the study (example: systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, and drugs with known liver toxicity).
Have donated blood of more than 500 milliliter (mL) or has undergone major surgery
The use of caffeine containing products and alcohol is not allowed from 12 hours prior to all study visits and during in clinic stays. All other times, alcohol consumption and caffeine intake are limited to no more than 2 alcoholic beverages or equivalent (beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits (25 milliliter [mL/1 ounce]) per day and caffeinated beverages will be limited to no more than 2 units per day amounts (1 unit=120 milligrams [mg] of caffeine). Strenuous activity is not allowed from 1 week prior to admission until the follow-up visit.
Are smokers within the previous 6 months
Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer)prior to dosing or have received a vaccination within 1 month
Have a history of multiple or severe allergies or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs or food
Are immunocompromised
Have had cancer or within the past 5 years
Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (example: chili peppers)
Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to treatment period
Have excessive hair growth on the volar surface of the forearm or subjects currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
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. | Leuven | Belgium |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1 mg Single Dose LY2951742 | Single dose 1 milligram (mg) LY2951742 administered subcutaneously. |
| FG001 | 5 mg Single Dose LY2951742 | Single dose 5 mg LY2951742 administered subcutaneously. |
| FG002 | 25 mg Single Dose LY2951742 | Single dose 25 mg LY2951742 administered subcutaneously. |
| FG003 | 75 mg Single Dose LY2951742 | Single dose 75 mg LY2951742 administered subcutaneously. |
| FG004 | 200 mg Single Dose LY2951742 | Single dose 200 mg LY2951742 administered subcutaneously. |
| FG005 | 600 mg Single Dose LY2951742 | Single dose 600 mg LY2951742 administered subcutaneously. |
| FG006 | Placebo Single Dose | Single dose matched placebo administered subcutaneously. |
| FG007 | Placebo Multiple Dose | Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses). |
| FG008 | 150 mg Multiple Dose LY2951742 | Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1 mg Single Dose LY2951742 | Single dose 1 mg LY2951742 administered subcutaneously. |
| BG001 | 5 mg Single Dose LY2951742 | Single dose 5 mg LY2951742 administered subcutaneously. |
| 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 Clinically Significant Effects | Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module. | Safety Population: All participants who received at least 1 dose of the study drug. | Posted | Number | participants | Baseline up to 6 months (study completion) |
|
Not provided
Not provided
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 | 1 mg Single Dose LY2951742 | Single dose 1 mg LY2951742 administered subcutaneously. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly Company | 1-800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D010146 | Pain |
| D009437 | Neuralgia |
| D006261 | Headache |
| 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
| Single dose placebo | Placebo Comparator | Administered single subcutaneous injection |
|
| Multiple dose placebo | Placebo Comparator | Administered subcutaneously every 2 weeks for 6 weeks (4 doses) |
|
| 150 mg LY2951742 | Experimental | Administered subcutaneously every 2 weeks for 6 weeks (4 doses) |
|
| Placebo | Drug | Administered subcutaneously |
|
| Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax) | Day 43 up to Day 57 |
| Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC) | Day 43 up to Day 57 |
| BG002 | 25 mg Single Dose LY2951742 | Single dose 25 mg LY2951742 administered subcutaneously. |
| BG003 | 75 mg Single Dose LY2951742 | Single dose 75 mg LY2951742 administered subcutaneously. |
| BG004 | 200 mg Single Dose LY2951742 | Single dose 200 mg LY2951742 administered subcutaneously. |
| BG005 | 600 mg Single Dose LY2951742 | Single dose 600 mg LY2951742 administered subcutaneously. |
| BG006 | Placebo Single Dose | Single dose matched placebo administered subcutaneously. |
| BG007 | Placebo Multiple Dose | Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses). |
| BG008 | 150 mg Multiple Dose LY2951742 | Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses). |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 25 mg Single Dose LY2951742 | Single dose 25 mg LY2951742 administered subcutaneously. |
| OG003 | 75 mg Single Dose LY2951742 | Single dose 75 mg LY2951742 administered subcutaneously. |
| OG004 | 200 mg Single Dose LY2951742 | Single dose 200 mg LY2951742 administered subcutaneously. |
| OG005 | 600 mg Single Dose LY2951742 | Single dose 600 mg LY2951742 administered subcutaneously. |
| OG006 | Placebo Single Dose | Single dose matched placebo administered subcutaneously. |
| OG007 | Placebo Multiple Dose | Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses). |
| OG008 | 150 mg Multiple Dose LY2951742 | Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses). |
|
|
| Secondary | Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax) | Pharmacokinetic (PK) Population: All participants who received single dose LY2951742 study drug with interpretable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 up to Day 84 or early discontinuation |
|
|
|
| Secondary | Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC) | PK Population: All participants who received single dose LY2951742 study drug with interpretable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*day per milliliter (ng*day/mL) | Day 1 up to Day 84 or early discontinuation |
|
|
|
| Secondary | Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax) | PK Population: All participants who received multiple doses LY2951742 study drug with interpretable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 43 up to Day 57 |
|
|
|
| Secondary | Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC) | PK Population: All participants who received multiple dose LY2951742 study drug with interpretable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*day/mL | Day 43 up to Day 57 |
|
|
|
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | 5 mg Single Dose LY2951742 | Single dose 5 mg LY2951742 administered subcutaneously. | 0 | 7 | 5 | 7 |
| EG002 | 25 mg Single Dose LY2951742 | Single dose 25 mg LY2951742 administered subcutaneously. | 0 | 7 | 7 | 7 |
| EG003 | 75 mg Single Dose LY2951742 | Single dose 75 mg LY2951742 administered subcutaneously. | 0 | 7 | 4 | 7 |
| EG004 | 200 mg Single Dose LY2951742 | Single dose 200 mg LY2951742 administered subcutaneously. | 0 | 7 | 7 | 7 |
| EG005 | 600 mg Single Dose LY2951742 | Single dose 600 mg LY2951742 administered subcutaneously. | 0 | 7 | 5 | 7 |
| EG006 | Placebo Single Dose | Single dose matched placebo administered subcutaneously. | 0 | 12 | 9 | 12 |
| EG007 | Placebo Multiple Dose | Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses). | 0 | 2 | 2 | 2 |
| EG008 | 150 mg Multiple Dose LY2951742 | Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses). | 0 | 7 | 7 | 7 |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Accommodation disorder | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sialoadenitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood immunoglobulin e increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Orthostatic heart rate response increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |