View Clinical Trial (Medical Research Study)

A First-in-human Randomized, Double-blind, Placebo-controlled, 4-part Study to Assess Safety, Tolerability, Pharmacokinetics (Including Open Label Study of Food Effect and Interaction With Simvastatin) and Pharmacodynamics of Interwoven Single- and Multip

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Conditions:		Dyslipidemia - Healthy Volunteers
Purpose:		This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.
Study Summary:
Criteria:		Inclusion Criteria: - Healthy male and female subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening. - OR untreated dyslipidemic patients. - Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2. - Able to communicate well with the investigator, to understand and comply with the requirements of the study. Exclusion Criteria: - Use of other investigational drugs at the time of enrollment. - Active treatment for type 1 diabetes or type 2 diabetes mellitus. - A past medical history of ECG abnormalities, documented cardiac arrhythmias or cardiovascular diseases. - History of malignancy of any organ system, treated or untreated, within the past 5 years. - Pregnant or nursing (lactating) women. - Smokers. - Use of any prescription drugs, herbal supplements and/or over-the-counter (OTC) medication, dietary supplements. - History of drug or alcohol abuse within the 12 months prior to dosing. - 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.
NCT ID:		NCT01487460
Primary Contact:		Study Director Novartis Pharmaceuticals Novartis Pharmaceuticals
Backup Contact:		N/A
Location Contact:		Miramar, Florida 33025 United States There is no listed contact information for this specific location. Site Status: N/A

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