Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

Dyslipidaemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632358
• Other study ID #: CTAP311X2201
• Secondary ID: 2012-000857-29
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2012
• Last updated: November 27, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJordan: Ethical Committee, JFDALithuania: State Medicine Control Agency - Ministry of HealthRussia: Ministry of Health of the Russian FederationTaiwan: Department of HealthLithuania: Bioethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Pharmacological Committee, Ministry of HealthTaiwan: Center for Drug EvaluationTaiwan: Institutional Review BoardTaiwan: National Bureau of Controlled Drugs
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidemias

Intervention

Drug:
• TAP311 capsules

• Placebo

Locations

Country	Name	City	State
Jordan	Novartis Investigative Site	Amman
Taiwan	Novartis Investigative Site	Taichung
United States	Novartis Investigative Site	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Jordan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data	The Racc ratio from the plasma concentration-time data	Day 14	No
Secondary	Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data	The AUCtau, from the plasma concentration-time data	Day 14	No