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| ID | Type | Description | Link |
|---|---|---|---|
| I2M-MC-GSDA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7.5 mg LY2541546 - IV | Experimental | Single dose of 7.5 mg LY2541546 administered intravenously (IV) |
|
| 25 mg LY2541546 - IV | Experimental | Single dose of 25 mg LY2541546 administered IV |
|
| 75 mg LY2541546 - IV | Experimental | Single dose of 75 mg LY2541546 administered IV |
|
| 225 mg LY2541546 - IV | Experimental | Single dose of 225 mg LY2541546 administered IV |
|
| 750 mg LY2541546 - IV | Experimental | Single dose of 750 mg LY2541546 administered IV |
|
| 150 mg LY2541546 - SC | Experimental | Single dose of 150 mg LY2541546 administered subcutaneous (SC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2541546 - 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 AE from this study that results in one of the following outcomes:
| Day 1 through Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime | |
| Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criterion for Participants in Double Blind Groups Only
Additional Exclusion Criterion for Participants in Open Label Groups
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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 | Evansville | Indiana | 47710 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 7.5 mg LY2541546 - IV | Single dose of 7.5 mg LY2541546 administered intravenously (IV) |
| FG001 | 25 mg LY2541546 - IV | Single dose of 25 mg LY2541546 administered IV |
| FG002 | 75 mg LY2541546 - IV | Single dose of 75 mg LY2541546 administered IV |
| FG003 | 225 mg LY2541546 - IV | Single dose of 225 mg LY2541546 administered IV |
| FG004 | 750 mg LY2541546 - IV | Single dose of 750 mg LY2541546 administered IV |
| FG005 | 150 mg LY2541546 - SC | Single dose of 150 mg LY2541546 administered subcutaneous (SC) |
| FG006 | 225 mg LY2541546 - IV, OL | Single dose of 225 mg LY2541546 administered IV, open label (OL) |
| FG007 | 750 mg LY2541546 - IV, OL | Single dose of 750 mg LY2541546 administered IV, OL |
| FG008 | Placebo | Single dose of placebo administered IV or SC |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 7.5 mg LY2541546 - IV | Participants received 7.5 mg LY2541546 IV |
| BG001 | 25 mg LY2541546 - IV | Participants received25 mg LY2541546 IV |
| 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is any AE from this study that results in one of the following outcomes:
| All participants who received study drug. | Posted | Number | participants | Day 1 through Day 85 |
|
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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 | 7.5 mg LY2541546 - IV | Single dose of 7.5 mg LY2541546 administered intravenously (IV) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conduction disorder | Cardiac disorders | 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000593189 | blosozumab |
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|
| Placebo | Placebo Comparator | Single dose of placebo administered IV or SC |
|
| 225 mg LY2541546 - IV, OL | Experimental | Single dose of 225 mg LY2541546 administered IV, open label (OL) |
|
| 750 mg LY2541546 - IV, OL | Experimental | Single dose of 750 mg LY2541546 administered IV, OL |
|
|
| LY2541546 - SC | Drug | Administered SC |
|
| Placebo | Drug | Administered IV or SC |
|
A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan. |
| Baseline (predose), Day 29 anytime, Day 85 anytime |
| Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. | Baseline (predose), Day 29 anytime, Day 85 anytime |
| Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies. | Day 1: Predose, Day 29 anytime, Day 85 anytime |
| United States |
| 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 | Indianapolis | Indiana | 46202 | United States |
| BG002 | 75 mg LY2541546 - IV | Participants received 75 mg LY2541546 IV |
| BG003 | 225 mg LY2541546 - IV | Participants received225 mg LY541546 IV |
| BG004 | 750 mg LY2541546 - IV | Participants received750 mg LY2541546 IV |
| BG005 | 150 mg LY2541546 - SC | Participants received 150 mg LY2541546 subcutaneously (SC) |
| BG006 | 225 mg LY2541546 - IV, OL | Participants received 225 mg LY2541546 IV. Open label(OL) |
| BG007 | 750 mg LY2541546 - IV, OL | Participants received 750 mg LY2541546 IV, OL |
| BG008 | Placebo | Participants single dose of placebo administered IV or SC |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Single dose of 25 mg LY2541546 administered IV |
| OG002 | 75 mg LY2541546 - IV | Single dose of 75 mg LY2541546 administered IV |
| OG003 | 225 mg LY2541546 - IV | Single dose of 225 mg LY2541546 administered IV |
| OG004 | 750 mg LY2541546 - IV | Single dose of 750 mg LY2541546 administered IV |
| OG005 | 150 mg LY2541546 - SC | Single dose of 150 mg LY2541546 administered subcutaneous (SC) |
| OG006 | Placebo | Single dose of placebo administered IV or SC |
| OG007 | 225 mg LY2541546 - IV, OL | Single dose of 225 mg LY2541546 administered IV, open label (OL) |
| OG008 | 750 mg LY2541546 - IV, OL | Single dose of 750 mg LY2541546 administered IV, OL |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | All participants who received study drug and had sufficient evaluable results for PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomol*hr/mL | Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan. | All participants who received study drug and had evaluable results at the analyzed time points. | Posted | Least Squares Mean | 90% Confidence Interval | gram per square centimeter (g/cm^2) | Baseline (predose), Day 29 anytime, Day 85 anytime |
|
|
|
| Secondary | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. | All participants who received study drug and had evaluable results at the analyzed timepoints. | Posted | Least Squares Mean | 90% Confidence Interval | percentage of change from baseline | Baseline (predose), Day 29 anytime, Day 85 anytime |
|
|
|
| Secondary | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies. | All participants who received study drug and had evaluable results at the analyzed time points. | Posted | Count of Participants | Participants | No | Day 1: Predose, Day 29 anytime, Day 85 anytime |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 25 mg LY2541546 - IV | Single dose of 25 mg LY2541546 administered IV | 0 | 6 | 6 | 6 |
| EG002 | 75 mg LY2541546 - IV | Single dose of 75 mg LY2541546 administered IV | 0 | 6 | 4 | 6 |
| EG003 | 225 mg LY2541546 - IV | Single dose of 225 mg LY2541546 administered IV | 0 | 6 | 4 | 6 |
| EG004 | 750 mg LY2541546 - IV | Single dose of 750 mg LY2541546 administered IV | 0 | 6 | 4 | 6 |
| EG005 | 150 mg LY2541546 - SC | Single dose of 150 mg LY2541546 administered subcutaneous (SC) | 0 | 6 | 5 | 6 |
| EG006 | Placebo | Single dose of placebo administered IV or SC | 0 | 12 | 7 | 12 |
| EG007 | 225 mg LY2541546 - IV, OL | Single dose of 225 mg LY2541546 administered IV, open label (OL) | 0 | 6 | 6 | 6 |
| EG008 | 750 mg LY2541546 - IV, OL | Single dose of 750 mg LY2541546 administered IV, OL | 0 | 6 | 5 | 6 |
| Ventricular tachycardia | Cardiac disorders | 10.1 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | 10.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | 10.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | 10.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | 10.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | 10.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | 10.1 | Systematic Assessment |
|
| Visual disturbance | Eye disorders | 10.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 10.1 | Systematic Assessment |
|
| Application site irritation | General disorders | 10.1 | Systematic Assessment |
|
| Catheter site erythema | General disorders | 10.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | 10.1 | Systematic Assessment |
|
| Fatigue | General disorders | 10.1 | Systematic Assessment |
|
| Nodule | General disorders | 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 10.1 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | 10.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | 10.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | 10.1 | Systematic Assessment |
|
| Myringitis | Infections and infestations | 10.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 10.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | 10.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | 10.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | 10.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | 10.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 10.1 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | 10.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | 10.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | 10.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 10.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 10.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | 10.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 10.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 10.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 10.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 10.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | 10.1 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | 10.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 10.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | 10.1 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | 10.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | 10.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 10.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | 10.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | 10.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | 10.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 10.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | 10.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | 10.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | 10.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | 10.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | 10.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 10.1 | Systematic Assessment |
|
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|
| Day 85 |
|
|
|
| Day 85 |
|
|
| Day 29 |
|
| Day 85 |
|