A Randomized, Double-blind, Placebo-controlled, Single Dose, Parallel Group Study to Assess the Safety, Tolerability, Bioavailability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous LGT209 in Hypercholesterolemic Patients on Stable Doses of Atorvastatin or Simvastatin and in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- LGT209 300 mg
- Conditions
- Hypercholesterolemia
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers: Male and female subjects 18 to 70 years of age, in general good health with fasting LDL-cholesterol \>90 mg/dL and fasting serum triglycerides \<400 mg/dL
- •Patients on statin therapy: Male and female patients 18 to 70 years of age receiving atorvastatin or simvastatin and with fasting LDL-cholesterol \>90 mg/dL and fasting serum triglycerides \<400 mg/dL
Exclusion Criteria
- •Healthy volunteers:
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •Women of child-bearing potential unless using highly effective methods of contraception
- •Conditions which might impact the safety or biologic activity of the study drug
- •Statin patients:
- •Use of concomitant medications known to impact the safe use or efficacy of atorvastatin and simvastatin based on drug labels
- •Women of childbearing potential unless using highly effective methods of contraception during dosing and for at least 100 days after study drug administration
- •Conditions which might impact the safety or biologic activity of the study drug
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Patient: LGT209 300 mg
300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients
Intervention: LGT209 300 mg
Patient: LGT209 50 mg
50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients
Intervention: LGT209 50 mg
Patient: LGT209 50 mg
50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients
Intervention: Statins (atorvastatin or simvastatin)
Patient: LGT209 300 mg
300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients
Intervention: Statins (atorvastatin or simvastatin)
Healthy Volunteers: LGT209 300 mg
300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers
Intervention: LGT209 300 mg
Patient: Placebo
matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients
Intervention: Placebo
Patient: Placebo
matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients
Intervention: Statins (atorvastatin or simvastatin)
Healthy volunteers: Placebo
matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers
Intervention: Placebo
Outcomes
Primary Outcomes
Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death
Time Frame: 12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration
Time Frame: baseline and 12 weeks
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration
Time Frame: baseline and 12 weeks
Plasma concentrations of LGT209 following subcutaneous administration
Time Frame: 12 weeks
Secondary Outcomes
- Serum concentrations of PCSK9(12 weeks)
- Plasma concentrations of atorvastatin in patients(2 weeks)
- Plasma concentrations of simvastatin in patients(2 weeks)