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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

November 28, 2011
August 20, 2012
November 2011
June 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01487460 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Dyslipidemia
  • Healthy Volunteers
Drug: TAP311
  • Experimental: TAP311 in Healthy Volunteers
    Intervention: Drug: TAP311
  • Placebo Comparator: Matching Placebo
    Healthy Volunteers and Patients will be treated in Placebo group.
    Intervention: Drug: TAP311
  • Experimental: TAP311 and Simvastatin
    Intervention: Drug: TAP311
  • Experimental: TAP311 in Patients
    Intervention: Drug: TAP311
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01487460
CTAP311X2101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP