Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Dyslipidemia
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01487460
Start Date
November 1 2011
End Date
June 1 2012
Last Update
December 21 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Miramar, Florida, United States, 33025