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Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

Primary Purpose

Dyslipidaemia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAP311 capsules
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidaemia focused on measuring safety, tolerability, pharmacokinetics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAP311 capsules

Placebo of TAP311 capsules

Arm Description

Patients will receive TAP311 capsule orally once daily for 14 days.

Matching placebo to TAP311 capsule, once daily for 14 days

Outcomes

Primary Outcome Measures

Number of patients with adverse events
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)
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)
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)
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
The Racc ratio from the plasma concentration-time data
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data
The AUCtau, from the plasma concentration-time data

Full Information

First Posted
June 28, 2012
Last Updated
November 27, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01632358
Brief Title
Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidaemia
Keywords
safety, tolerability, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP311 capsules
Arm Type
Experimental
Arm Description
Patients will receive TAP311 capsule orally once daily for 14 days.
Arm Title
Placebo of TAP311 capsules
Arm Type
Placebo Comparator
Arm Description
Matching placebo to TAP311 capsule, once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
TAP311 capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.
Time Frame
14 days after treatment
Secondary Outcome Measure Information:
Title
Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)
Description
Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure
Time Frame
Day 1 and Day 14
Title
Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
Description
The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
Time Frame
Day 1 and Day 14 profile
Title
Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Description
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time Frame
Day 1
Title
Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data
Description
The Racc ratio from the plasma concentration-time data
Time Frame
Day 14
Title
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data
Description
The AUCtau, from the plasma concentration-time data
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Novartis Investigative Site
City
Amman
ZIP/Postal Code
11941
Country
Jordan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan

12. IPD Sharing Statement

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Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

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