Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients - Full Text View

Purpose

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

Condition	Intervention	Phase
Dyslipidaemia	Drug: TAP311 capsules Drug: Placebo	Phase 1

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Number of patients with adverse events [ Time Frame: 14 days after treatment ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 1 and Day 14 profile ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
The Racc ratio from the plasma concentration-time data
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
The AUCtau, from the plasma concentration-time data

Estimated Enrollment:	30
Study Start Date:	June 2012
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632358

Contacts

Contact: Novartis Pharmaceuticals

+1(862)778-8300

Locations

United States, Florida
Novartis Investigative Site	Recruiting
Miramar, Florida, United States, 33025
Jordan
Novartis Investigative Site	Recruiting
Amman, Jordan, 11941
Lithuania
Novartis Investigative Site	Not yet recruiting
Vilnius, Lithuania, LT-08661
Russian Federation
Novartis Investigative Site	Not yet recruiting
Moscow, Russian Federation, 117292
Taiwan
Novartis Investigative Site	Recruiting
Taichung, Taiwan, 40447

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01632358 History of Changes
Other Study ID Numbers:	CTAP311X2201, 2012-000857-29
Study First Received:	June 28, 2012
Last Updated:	October 2, 2012
Health Authority:	United States: Food and Drug Administration Jordan: Ethical Committee, JFDA Lithuania: State Medicine Control Agency - Ministry of Health Russia: Ministry of Health of the Russian Federation Taiwan: Department of Health Lithuania: Bioethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Russia: Pharmacological Committee, Ministry of Health Taiwan: Center for Drug Evaluation Taiwan: Institutional Review Board Taiwan: National Bureau of Controlled Drugs

Keywords provided by Novartis:

safety
tolerability
pharmacokinetics

Additional relevant MeSH terms:

Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013