Clinical trial NCT01632358: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidaemia
Keywords: safety
tolerability
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-07-02
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 14 days after treatment
Secondary outcomes:
measure: Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)
timeFrame: Day 1 and Day 14
measure: Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
timeFrame: Day 1 and Day 14 profile
measure: Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
timeFrame: Day 1
measure: Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data
timeFrame: Day 14
measure: Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data
timeFrame: Day 14
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Novartis Investigative Site
state: Florida
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: