Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01632358
• Date of registration: 28/06/2012
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients
• Scientific 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
• Date of first enrolment: June 2012
• Target sample size: 279
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01632358
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Jordan, Lithuania, Russian Federation, Taiwan, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dyslipidaemia

Intervention(s)

Drug: TAP311 capsules

Drug: Placebo

Primary Outcome(s)

Number of patients with adverse events [Time Frame: 14 days after treatment]

Secondary Outcome(s)

Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data [Time Frame: Day 14]

Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data [Time Frame: Day 14]

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]

Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Time Frame: Day 1 and Day 14]

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]

Secondary ID(s)

2012-000857-29

CTAP311X2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors