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

Hyperlipoproteinemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146522
• Other study ID #: CLCQ908A2212
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemia
• Hyperlipoproteinemias
• Hypertriglyceridemia

Intervention

Drug:
• LCQ908

• Placebo

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)		after 3 weeks of treatment with each dose

External Links

•   Results for CLCQ908A2212 from the Novartis Clinical Trials website