Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

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

Official Title
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A Randomized, Double-blind, Placebo Controlled, Crossover Study to Assess Safety and Tolerability, Pharmacokinetics, and Explore Pharmacodynamics of TAP311 in Patients With Mixed Dyslipidaemia

Conditions
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Dyslipidaemia

Intervention / Treatment
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* Drug: TAP311 capsules
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP311 capsules<br>Patients will receive TAP311 capsule orally once daily for 14 days. | Drug: TAP311 capsules<br> <br> |
| Placebo Comparator: Placebo of TAP311 capsules<br>Matching placebo to TAP311 capsule, once daily for 14 days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data | The Racc ratio from the plasma concentration-time data | Day 14 | 
| Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data | The AUCtau, from the plasma concentration-time data | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, tolerability, pharmacokinetics