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This study is designed to measure the effects of LGT209 when given intravenously to patients with high cholesterol who are on stable doses of statin medications, and to healthy subjects with elevated cholesterol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient: LGT209 0.3 mg/kg | Experimental | 0.3 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
|
| Patient: LGT209 1 mg/kg | Experimental | 1 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
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| Patient: LGT209 3 mg/kg | Experimental | 3 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
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| Patient: LGT209 10 mg/kg | Experimental | 10 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
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| Patient: LGT209 20 mg/kg | Experimental | 20 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
|
| Healthy Volunteers: LGT209 0.3 mg/kg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGT209 | Drug | 150 mg lyophilized powder in glass vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events, serious adverse events and death | from Screening until Day 141 | |
| Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration in healthy volunteers | Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1) | Baseline, Day 29 |
| Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) in healthy volunteers | Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1) | Baseline, Day 29 |
| Pharmacokinetics of LGT209: : Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2); 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 | |
| Pharmacokinetics of LGT209: observed maximum serum concentrations (Cmax) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 | |
| Pharmacokinetics of LGT209: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of intravenous LGT209 in relationship to concentrations of PCSK9 and LDL-C in patients and healthy volunteers | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 | |
| Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration in patients |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Miami Gardens | Florida | 33169 | United States | ||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| C566337 | Hypercholesterolemia, Autosomal Dominant, 3 |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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0.3 mg/kg LGT209 intravenous administration in healthy volunteers
|
| Healthy Volunteers: LGT209 1 mg/kg | Experimental | 1 mg/kg LGT209 intravenous administration in healthy volunteers |
|
| Healthy Volunteers: LGT209 3 mg/kg | Experimental | 3 mg/kg LGT209 intravenous administration in healthy volunteers |
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| Healthy Volunteers: LGT209 10 mg/kg | Experimental | 10 mg/kg LGT209 intravenous administration in healthy volunteers |
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| Healthy Volunteers: 20 mg/kg | Experimental | 20 mg/kg LGT209 intravenous administration in healthy volunteers |
|
| Patient: Placebo | Placebo Comparator | Matching intravenous placebo in patients on stable doses of statins |
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| Healthy Volunteers: Placebo | Placebo Comparator | Matching intravenous placebo in healthy volunteers |
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| Placebo | Drug | Placebo comparator |
|
| Pharmacokinetics of LGT209: Elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve (T1/2) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Number of healthy volunteers with adverse events, serious adverse events and death | from Screening until Day 141 |
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1) |
| Baseline, Day 29 |
| Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) in patients | Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1) | Baseline, Day 29 |
| Pharmacokinetics of LGT209: Area under the serum concentration-time curve from time zero to time 't' (AUC0-t) | In AUC 0-t, t is a defined as time point after administration of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Pharmacokinetics of LGT209: Dose-normalized area under the serum concentration-time curve (AUC/D) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Pharmacokinetics of LGT209: Dose-normalized maximum serum concentrations (Cmax/D) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 ( 1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Pharmacokinetics of LGT209: Volume of distribution during the terminal elimination phase (Vz) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Pharmacokinetics of LGT209: Volume of distribution at steady state (Vss) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Pharmacokinetics of LGT209: Mean residence time (MRT) of LGT209 in patients and healthy volunteers following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Pharmacokinetics of LGT209: the systemic (or total body) clearance from serum following intravenous administration | Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141 |
| Fargo |
| North Dakota |
| 58104 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |