Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

A Randomized, Double-blind, Placebo Controlled, Crossover Study to Assess Safety and Tolerability, Pharmacokinetics, and Explore Pharmacodynamics of TAP311 in Patients With Mixed Dyslipidaemia

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

Study Overview

• Status: Completed
• Conditions: Dyslipidaemia
• Intervention / Treatment: Drug: Placebo; Drug: TAP311 capsules

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11941
    • Novartis Investigative Site
• Taiwan
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
• United States
  • Florida
    • Miramar, Florida, United States, 33025
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events	Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.	14 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)	Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure	Day 1 and Day 14
Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)	The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)	Day 1 and Day 14 profile
Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)	The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)	Day 1
Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data	The Racc ratio from the plasma concentration-time data	Day 14
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data	The AUCtau, from the plasma concentration-time data	Day 14

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): July 2, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: tolerability; safety; pharmacokinetics
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CTAP311X2201; 2012-000857-29