Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

Phase 1

Completed

• Conditions: Dyslipidaemia
• Interventions: Drug: TAP311 capsules; Drug: Placebo

• Registration Number: NCT01632358
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TAP311 capsules	TAP311 capsules	Patients will receive TAP311 capsule orally once daily for 14 days.
Placebo of TAP311 capsules	Placebo	Matching placebo to TAP311 capsule, once daily for 14 days

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	14 days after treatment	Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)	Day 1	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	Day 14	The Racc ratio from the plasma concentration-time data
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data	Day 14	The AUCtau, from the plasma concentration-time data
Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)	Day 1 and Day 14	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)	Day 1 and Day 14 profile	The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Taichung, Taiwan