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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01146522

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperlipoproteinemia	Drug: LCQ908 Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 V)

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LCQ908	Drug: LCQ908
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: LCQ908

Drug: LCQ908

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Blood concentration to characterize LCQ908 kinetics [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) [after 3 weeks of treatment with each dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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