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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hyperlipoproteinemia

Treatments: Drug: Placebo; Drug: LCQ908

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146522

CLCQ908A2212

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

LCQ908

Experimental group

Treatment:

Drug: LCQ908

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo