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Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

NCT ID: NCT01632358

Last Updated: 2013-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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Conditions

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Dyslipidaemia

Keywords

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safety tolerability pharmacokinetics

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAP311 capsules

Patients will receive TAP311 capsule orally once daily for 14 days.

Group Type EXPERIMENTAL

TAP311 capsules

Intervention Type DRUG

Placebo of TAP311 capsules

Matching placebo to TAP311 capsule, once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TAP311 capsules

Intervention Type DRUG

Placebo

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Miramar, Florida, United States

Site Status

Novartis Investigative Site

Amman, , Jordan

Site Status

Novartis Investigative Site

Taichung, Taiwan, Taiwan

Site Status

Countries

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Lithuania Russia United States Jordan Taiwan

Other Identifiers

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2012-000857-29

Identifier Type: -

Identifier Source: secondary_id

CTAP311X2201

Identifier Type: -

Identifier Source: org_study_id