Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypercholesterolemia
LDL Cholesterol
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 volunte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01859455
Start Date
July 1 2011
End Date
July 1 2012
Last Update
December 17 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Fort Myers, Florida, United States, 33901-8144
2
Novartis Investigative Site
Miramar, Florida, United States, 33025