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| ID | Type | Description | Link |
|---|---|---|---|
| I1Q-JE-JDDH | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single IV dose LY2495655 | Experimental | Single 70 milligram (mg) dose LY2495655 administered intravenously (IV) |
|
| Multiple SC dose 17.5 mg LY2495655 | Experimental | 17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
|
| Multiple SC dose 140 mg LY2495655 | Experimental | 140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses) |
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| Multiple SC dose 420 mg LY2495655 | Experimental | 420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses) |
|
| Single IV dose placebo | Placebo Comparator | Single Placebo dose administered intravenously (IV) |
|
| Multiple SC dose placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2495655 | Drug | administered intravenously or subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module. | Baseline to study completion (up to 135 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Maximum Concentration (Cmax) | Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose | |
| Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC) |
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Inclusion Criteria
Single dose cohort
Multiple dose cohorts
All subjects
Exclusion Criteria:
Single dose cohort
Multiple dose cohort
All subjects
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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. | Honolulu | Hawaii | 96814 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single IV Dose 70 mg LY2495655 | Single 70 milligram (mg) dose LY2495655 administered intravenously (IV) |
| FG001 | Multiple SC Dose 17.5 mg LY2495655 | 17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
| FG002 | Multiple SC Dose 140 mg LY2495655 | 140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) |
| FG003 | Multiple SC Dose 420 mg LY2495655 | 420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) |
| FG004 | Single IV Dose Placebo | Single placebo dose administered intravenously (IV) |
| FG005 | Multiple SC Dose Placebo | Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Single IV Dose 70 mg LY2495655 | Single 70 milligram (mg) dose LY2495655 administered intravenously (IV) |
| BG001 | Multiple SC Dose 17.5 mg LY2495655 | 17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
| Units | Counts |
|---|---|
| Participants |
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| 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 are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module. | All randomized participants | Posted | Count of Participants | Participants | No | Baseline to study completion (up to 135 days) |
|
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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 | Single IV Dose 70 mg LY2495655 | Single 70 milligram (mg) dose LY2495655 administered intravenously (IV) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000607476 | landogrozumab |
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Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
|
| Placebo | Drug | administered intravenously or subcutaneously |
|
Area under the concentration curve (AUC) time zero to infinity (0-inf) was calculated for single dose administration and AUCtau (AUCτ) at steady state was calculated for multiple dose administration. |
| Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose |
| Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax) | Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose |
| Percentage Change in Thigh Muscle Volume | Thigh muscle volume was determined by Magnetic Resonance Imaging (MRI) scan of the right leg thigh muscle. Percentage change in thigh muscle volume=(time point value-baseline value)*100. Change from baseline for muscle volume was analyzed using mixed model repeated measures (MMRM) model with fixed effects of treatment, time and treatment*time interaction and a random effect of subject where baseline values were included as a covariate. | Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose arms |
| United States |
| BG002 | Multiple SC Dose 140 mg LY2495655 | 140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) |
| BG003 | Multiple SC Dose 420 mg LY2495655 | 420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) |
| BG004 | Single IV Dose Placebo | Single placebo dose administered intravenously (IV) |
| BG005 | Multiple SC Dose Placebo | Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| International Physical Activity Questionnaire (IPAQ) | IPAQ assessed physical activity, walking, moderate-intensity activities and vigorous-intensity activities. The total IPAQ score is computed by weighting each type of activity by its energy requirements defined in Metabolic Equivalent Tasks (METs). A MET-minute score is multiplied by an activity by the minutes performed (MET-minute=kilocalories for a 60 kilogram person). Data is expressed as MET-min per week: MET level x minutes of activity x events per week. A MET-min per week score below 600 is considered low physical activity (sedentary) and a score above 600 is high physical activity. | Mean | Standard Deviation | MET-minutes per week |
|
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
| OG002 | Multiple SC Dose 140 mg LY2495655 | 140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) |
| OG003 | Multiple SC Dose 420 mg LY2495655 | 420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) |
| OG004 | Single IV Dose Placebo | Single placebo dose administered intravenously (IV) |
| OG005 | Multiple SC Dose Placebo | Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
|
|
| Secondary | Pharmacokinetics, Maximum Concentration (Cmax) | All participants who received study drug and had evaluable Cmax data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles per milliliter (pmol/mL) | Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose |
|
|
|
| Secondary | Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC) | Area under the concentration curve (AUC) time zero to infinity (0-inf) was calculated for single dose administration and AUCtau (AUCτ) at steady state was calculated for multiple dose administration. | All participants who received study drug and had evaluable AUC data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles*hour per milliliter(nmol*h/mL) | Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose |
|
|
|
| Secondary | Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax) | All participants who received study drug and had evaluable Tmax data were analyzed. | Posted | Median | Full Range | hours (h) | Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose |
|
|
|
| Secondary | Percentage Change in Thigh Muscle Volume | Thigh muscle volume was determined by Magnetic Resonance Imaging (MRI) scan of the right leg thigh muscle. Percentage change in thigh muscle volume=(time point value-baseline value)*100. Change from baseline for muscle volume was analyzed using mixed model repeated measures (MMRM) model with fixed effects of treatment, time and treatment*time interaction and a random effect of subject where baseline values were included as a covariate. | All randomized participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | percentage change | Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose arms |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | Multiple SC Dose 17.5 mg LY2495655 | 17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) | 0 | 9 | 9 | 9 |
| EG002 | Multiple SC Dose 140 mg LY2495655 | 140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) | 0 | 10 | 10 | 10 |
| EG003 | Multiple SC Dose 420 mg LY2495655 | 420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses) | 0 | 10 | 10 | 10 |
| EG004 | Single IV Dose Placebo | Single placebo dose administered intravenously (IV) | 0 | 2 | 2 | 2 |
| EG005 | Multiple SC Dose Placebo | Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) | 0 | 10 | 7 | 10 |
| Eye irritation | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Nail injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Sleep phase rhythm disturbance | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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Not provided
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| Day 57 |
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| Day 57 |
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| Day 57 |
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| Day 71 |
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