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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01487460
First received: November 28, 2011
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  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.


Condition Intervention Phase
Dyslipidemia
Healthy Volunteers
 Drug: TAP311
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).


Secondary Outcome Measures:
  • TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia. [ Time Frame: 25 timepoints over 17 days ] [ Designated as safety issue: No ]
  • Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.

  • Effect of food on TAP311 blood concentration in healthy subjects. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    TAP311 blood concentration when the drug is administered with and without food.

  • Effects of TAP311 on total cholesterol in patients with dyslipidemia [ Time Frame: 8 timepoints over 15 days ] [ Designated as safety issue: No ]
    Total cholesterol blood concentration before and after TAP311 treatment.

  • Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia [ Time Frame: 8 timepoints over 15 days ] [ Designated as safety issue: No ]
    LDL-C blood concentration before and after TAP311 treatment.

  • Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia. [ Time Frame: 8 timepoints over 15 days ] [ Designated as safety issue: No ]
    HDL-C blood concentration before and after TAP311 treatment.

  • Effects of TAP311 on triglycerides in patients with Dyslipidemia [ Time Frame: 8 timepoints over 15 days ] [ Designated as safety issue: No ]
    Triglycerides concentration in blood before and after TAP311 treatment.


Enrollment: 137
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP311 in Healthy Volunteers Drug: TAP311
Placebo Comparator: Matching Placebo
Healthy Volunteers and Patients will be treated in Placebo group.
 Drug: TAP311
Experimental: TAP311 and Simvastatin Drug: TAP311
Experimental: TAP311 in Patients Drug: TAP311

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487460

Locations
United States, Florida
Novartis Investigative Site
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01487460     History of Changes
Other Study ID Numbers: CTAP311X2101
Study First Received: November 28, 2011
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
High cholesterol levels
Hyperlipidemia
High-density Lipoprotein
Low-density Lipoprotein
Simvastatin

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013