Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
Completed · Phase 1 · Has a placebo group
Conditions studied: Hypercholesterolemia, LDL Cholesterol
In brief
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.
Key facts
- Study ID
- NCT01859455
- Run by
- Novartis Pharmaceuticals
- People needed
- 25
- Starts
- 2011-07-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2020-12-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — Fort Myers, Florida, United States
- Novartis Investigative Site — Miramar, Florida, United States
Full record on ClinicalTrials.gov
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