Clinical Trial: Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and

Brief Summary: This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Fasting and postprandial plasma triglycerides [ Time Frame: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood concentration to characterize LCQ908 kinetics [ Time Frame: serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose ]
  • Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) [ Time Frame: after 3 weeks of treatment with each dose ]


Original Secondary Outcome:

  • Measuring the drug level (LCQ908) in serial blood samples collected from patients enrolled in the study [ Time Frame: after 3 weeks of treatment with each dose ]
  • Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) [ Time Frame: after 3 weeks of treatment with each dose ]


Information By: Novartis

Dates:
Date Received: June 9, 2010
Date Started: May 2010
Date Completion:
Last Updated: December 28, 2012
Last Verified: December 2012