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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01146522

First received: June 9, 2010

Last updated: December 28, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 9, 2010

Last Updated Date

December 28, 2012

Start Date ^ICMJE

May 2010

Primary Completion Date

October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01146522 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hyperlipoproteinemia

Intervention ^ICMJE

Drug: LCQ908
Drug: Placebo

Study Arms

Experimental: LCQ908
Intervention: Drug: LCQ908
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Meyers CD, Tremblay K, Amer A, Chen J, Jiang L, Gaudet D. Effect of the DGAT1 inhibitor pradigastat on triglyceride and apoB48 levels in patients with familial chylomicronemia syndrome. Lipids Health Dis. 2015 Feb 18;14:8. doi: 10.1186/s12944-015-0006-5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01146522

Other Study ID Numbers ^ICMJE

CLCQ908A2212

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

PRS Account

Novartis

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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