Clinical trial NCT01859455: Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
LDL Cholesterol
Keywords: Hypercholesterolemia,
LDL cholesterol lowering,
proprotein convertase subtilisin/kexin type 9 (PCSK9),
LGT209,
drug safety,
pharmacokinetics,
pharmacodynamics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death
timeFrame: 12 weeks
measure: Plasma concentrations of LGT209 following subcutaneous administration
timeFrame: 12 weeks
measure: Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration
timeFrame: baseline and 12 weeks
measure: Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Plasma concentrations of atorvastatin in patients
timeFrame: 2 weeks
measure: Plasma concentrations of simvastatin in patients
timeFrame: 2 weeks
measure: Serum concentrations of PCSK9
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miramar
country: United States
facility: Novartis Investigative Site
state: Florida
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: