Clinical trial NCT01487460: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Healthy Volunteers
Keywords: High cholesterol levels
Hyperlipidemia
High-density Lipoprotein
Low-density Lipoprotein
Simvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.


Eligibility 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.

Primary outcomes:
measure: Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia
timeFrame: Up to 21 days
Secondary outcomes:
measure: TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia.
timeFrame: 25 timepoints over 17 days
measure: Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.
timeFrame: 10 days
measure: Effect of food on TAP311 blood concentration in healthy subjects.
timeFrame: 3 days
measure: Effects of TAP311 on total cholesterol in patients with dyslipidemia
timeFrame: 8 timepoints over 15 days
measure: Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia
timeFrame: 8 timepoints over 15 days
measure: Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.
timeFrame: 8 timepoints over 15 days
measure: Effects of TAP311 on triglycerides in patients with Dyslipidemia
timeFrame: 8 timepoints over 15 days
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Novartis Investigative Site
state: Florida
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: