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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).

• Non breast feeding women.

• Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.

Exclusion Criteria:

Patients with:

• uncontrolled type 1 or type 2 diabetes mellitus,

• active pancreatitis (the month prior to study start),

• history of drug or alcohol abuse within the 12 months prior to dosing,

• or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply