Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859455
• Other study ID #: CLGT209X2105
• Status: Completed
• Phase: Phase 1
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• LDL Cholesterol

Intervention

Drug:
• LGT209 50 mg
Active experimental drug
• LGT209 300 mg
Active experimental drug
• Placebo
Placebo comparator
• Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death		12 weeks
Primary	Plasma concentrations of LGT209 following subcutaneous administration		12 weeks
Primary	Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration		baseline and 12 weeks
Primary	Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration		baseline and 12 weeks
Secondary	Plasma concentrations of atorvastatin in patients		2 weeks
Secondary	Plasma concentrations of simvastatin in patients		2 weeks
Secondary	Serum concentrations of PCSK9		12 weeks

External Links

•   Results for CLGT209X2105 can be found on the Novartis Clinical Trial Results Website