Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients… (NCT01146522) | Clinical Trial Compass
CompletedPhase 1/2
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
Canada8 participantsStarted 2010-05
Plain-language summary
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Fasting and postprandial plasma triglycerides
Timeframe: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment)