Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
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)
1 other identifier
interventional
8
1 country
1
Brief Summary
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedDecember 17, 2020
December 1, 2012
1.4 years
June 9, 2010
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
LCQ908
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Québec, Canada
Related Publications (1)
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.
PMID: 25889044DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2010
First Posted
June 17, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
December 17, 2020
Record last verified: 2012-12