Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01632358
First received: June 28, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.


Condition Intervention Phase
Dyslipidaemia
Drug: TAP311 capsules
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Crossover Study to Assess Safety and Tolerability, Pharmacokinetics, and Explore Pharmacodynamics of TAP311 in Patients With Mixed Dyslipidaemia

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 14 days after treatment ] [ Designated as safety issue: Yes ]
    Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.


Secondary Outcome Measures:
  • Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
    Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure

  • Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss) [ Time Frame: Day 1 and Day 14 profile ] [ Designated as safety issue: No ]
    The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)

  • Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)

  • Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The Racc ratio from the plasma concentration-time data

  • Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The AUCtau, from the plasma concentration-time data


Enrollment: 279
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP311 capsules
Patients will receive TAP311 capsule orally once daily for 14 days.
Drug: TAP311 capsules
Placebo Comparator: Placebo of TAP311 capsules
Matching placebo to TAP311 capsule, once daily for 14 days
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients 18 to 80 years (inclusive) of age.
  • Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
  • Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.

Exclusion Criteria:

  • Use of other investigational drugs at the time of enrollment
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  • Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
  • Pregnant or nursing (lactating) women
  • Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
  • Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).
  • Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception
  • Significant illness within two (2) weeks prior to initial dosing
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632358

Locations
United States, Florida
Novartis Investigative Site
Miramar, Florida, United States, 33025
Jordan
Novartis Investigative Site
Amman, Jordan, 11941
Taiwan
Novartis Investigative Site
Taichung, Taiwan, 40447
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: NCT01632358     History of Changes
Other Study ID Numbers: CTAP311X2201, 2012-000857-29
Study First Received: June 28, 2012
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration
Jordan: Ethical Committee, JFDA
Lithuania: State Medicine Control Agency - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Taiwan: Department of Health
Lithuania: Bioethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Pharmacological Committee, Ministry of Health
Taiwan: Center for Drug Evaluation
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs

Keywords provided by Novartis:
safety
tolerability
pharmacokinetics

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014