Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | June 2012 |
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 Multiple-ascending Doses of TAP311 in Healthy Subjects and Dyslipidemic Patients.
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.
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.
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.
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